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Meta-Analysis
. 2025 Apr 2;4(4):CD013342.
doi: 10.1002/14651858.CD013342.pub2.

Stem cell injections for osteoarthritis of the knee

Samuel L Whittle  1   2 , Renea V Johnston  1 , Steve McDonald  3 , Daniel Worthley  4 , T Mark Campbell  5 , Sheila Cyril  1 , Tanay Bapna  1 , Jason Zhang  1 , Rachelle Buchbinder  1
Affiliations
Meta-Analysis

Stem cell injections for osteoarthritis of the knee

Samuel L Whittle et al. Cochrane Database Syst Rev. .

Abstract

Background: Stem cells are specialised precursor cells that can replace aged or damaged cells and thereby maintain healthy tissue function. Stem cell therapy is increasingly used as a treatment for knee osteoarthritis, despite the lack of clarity around the mechanism by which stem cell therapy may slow down disease progression in osteoarthritis, and uncertainty regarding its benefits and harms.

Objectives: To assess the benefits and harms of stem cell injections for people with osteoarthritis of the knee. A secondary objective is to maintain the currency of the evidence, using a living systematic review approach.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase on 15 September 2023, unrestricted by date or language of publication. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for relevant trial protocols and ongoing trials.

Selection criteria: We included randomised controlled trials (RCTs), or trials using quasi-randomised methods of participant allocation, comparing stem cell injection with placebo injection, no treatment or usual care, glucocorticoid injection, other injections, exercise, drug therapy, surgical interventions, and supplements and complementary therapies in people with knee osteoarthritis.

Data collection and analysis: Two review authors selected studies for inclusion, extracted trial characteristics and outcome data, assessed risk of bias and assessed the certainty of evidence using the GRADE approach. The primary comparison was stem cell injection compared with placebo injection. The primary time point for pain, function and quality of life was three to six months, and the end of the trial period for participant-reported success, joint structure changes and adverse event outcomes. Major outcomes were pain, function, quality of life, global assessment of success, radiographic joint progression, withdrawals due to adverse events and serious adverse events.

Main results: We found 25 randomised trials (1341 participants) comparing stem cell injections with placebo injection (eight trials), no treatment or usual care (analgesia, weight loss and exercise) (two trials), glucocorticoid injection (one trial), hyaluronic acid injection (seven trials), platelet-rich plasma injections (two trials), oral acetaminophen (paracetamol) (one trial), non-steroidal anti-inflammatory drugs plus physical therapy plus hyaluronic acid injection (one trial) and stem cell injection plus intra-articular co-intervention versus co-intervention alone (three trials) in people with osteoarthritis of the knee. Trials were predominantly small, with sample sizes ranging from 6 to 252 participants, with only two trials having more than 100 participants. The average age of participants across trials ranged from 51 to 66 years, and symptom duration varied from one to 10 years. Placebo-controlled trials were largely free from bias, while most trials without a placebo control were susceptible to performance and detection biases. Here, we limit reporting to the main comparison, stem cell injection versus placebo injection. Compared with placebo injection, stem cell injection may slightly improve pain and function up to six months after treatment. Mean pain (0 to 10 scale, 0 no pain) was 4.5 out of 10 points with placebo injection and 1.2 points better (2.5 points better to 0 points better) with stem cell injection (I2 = 80%; 7 studies, 445 participants). Mean function (0 to 100 scale, 0 best function) was 46.3 points with placebo injection and 14.2 points better (25.3 points better to 3.1 points better) with stem cell injection (I2 = 82%; 7 studies, 432 participants). We are uncertain whether stem cell injections improve quality of life or increase the number of people who report treatment success compared to placebo injection, because the certainty of the evidence was very low. Mean quality of life was 45.3 points with placebo injection and 22.8 points better (18.0 points worse to 63.7 points better) with stem cell injection (I2 = 96%; 2 studies, 288 participants) at up to six months follow-up. At the end of follow-up, 89/168 participants (530 per 1000) in the placebo injection group reported treatment success compared with 126/180 participants (683 per 1000) in the stem cell injection group (risk ratio (RR) 1.29, 95% CI 1.10 to 1.53; I2 = 0%; 4 trials, 348 participants). We downgraded the evidence to low certainty for pain and function due to indirectness (as the source, method of preparation and dose of stem cells varied across studies), and suspected publication bias (up to three larger RCTs have been conducted but withdrawn prior to reporting of results). For quality of life and treatment success, we further downgraded the evidence to very low certainty due to imprecision in addition to indirectness and suspected publication bias. We are uncertain of the potential harms associated with stem cell injection, as there were very low event rates for serious adverse events. At the end of follow-up, 5/219 participants (23 per 1000) in the placebo injection group experienced serious adverse events compared with 4/242 participants (16 per 1000) in the stem cell injection group (RR 0.72, 95% CI 0.20 to 2.64; I2 = 0%; 7 trials, 461 participants) and there were no reported withdrawals due to adverse events. We downgraded the evidence to very low certainty due to indirectness, suspected publication bias and imprecision. Radiographic progression was not assessed in any of the included studies.

Authors' conclusions: Compared with placebo injections and based upon low-certainty evidence, stem cell injections for people with knee osteoarthritis may slightly improve pain and function. We are uncertain of the effects of stem cell injections on quality of life or the number who report treatment success. Although the putative benefits of stem cell therapies for osteoarthritis include potential regenerative effects on damaged tissues, particularly articular cartilage, we remain uncertain of the effect of stem cell injections on structural progression in the knee (measured by radiographic appearance). There is also uncertainty regarding the safety of stem cell injections. Serious adverse events were infrequently reported, although all invasive joint procedures (including injections) carry a small risk of septic arthritis. The risk of other important harms, including potential concerns related to the use of a therapy with the theoretical capacity to promote cell growth, or to the use of allogeneic cells, remains unknown.

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Conflict of interest statement

Renea Johnston, Rachelle Buchbinder and Steve McDonald are recipients of a National Health and Medical Research Council Cochrane Collaboration Round 7 Funding Program Grant, which supports the activities of Cochrane Musculoskeletal ‐ Australia and Cochrane Australia, but the funders did not participate in the conduct of this review.

Tanay Bapna is a medical student at Monash University.

Rachelle Buchbinder is a Rheumatologist (adult) and the Co‐ordinating Editor of Cochrane Musculoskeletal. She was not involved in the editorial process for this review. RB declares royalties for a book chapter on plantar fasciitis.

Mark Campbell is a health professional and conducts clinical work at Bruyere Continuing Care, Ottawa, Canada. His clinical activities include treating patients with osteoarthritis; however, stem cell use for osteoarthritis has never been a part of his practice.

Sheila Cyril is the Assistant Managing Editor of Cochrane Musculoskeletal. She was not involved in the editorial process for this review.

Renea Johnston is the Managing Editor of Cochrane Musculoskeletal. She was not involved in the editorial process for this review.

Steve McDonald is Co‐Director of Cochrane Australia and an Information Specialist with the Cochrane Central Editorial Service. He was not involved in the editorial process for this review.

Samuel Whittle is a Senior Consultant Rheumatologist at The Queen Elizabeth Hospital, Vice President of the Australian Rheumatology Association and a Cochrane Musculoskeletal Editor. He was not involved in the editorial process for this review.

Daniel Worthley declares a patent for osteochondroreticular stem cells for bone and cartilage regeneration (US‐20170335283‐A1), which is held by his previous institution.

Jason Zhang declares that he has no conflicts of interest.

Update of

References

References to studies included in this review

Anz 2020 {published data only}
    1. Anz AW, Hubbard R, Rendos NK, Everts PA, Andrews JR, Hackel JG. Bone marrow aspirate concentrate is equivalent to platelet-rich plasma for the treatment of knee osteoarthritis at 1 year: a prospective, randomized trial. Orthopaedic Journal of Sports Medicine 2020;8(2):2325967119900958. [DOI: 10.1177/2325967119900958] - DOI - PMC - PubMed
Baria 2022 {published data only}
    1. Baria M, Pedroza A, Kaeding C, Durgam S, Duerr R, Flanigan D, et al. Platelet-rich plasma versus microfragmented adipose tissue for knee osteoarthritis: a randomized controlled trial. Orthopedic Journal of Sports Medicine 2022;10(9):23259671221120678. - PMC - PubMed
Bastos 2020 {published data only}
    1. Bastos R, Mathias M, Andrade R, Amaral RJ, Schott V, Balduino A, et al. Intra-articular injection of culture-expanded mesenchymal stem cells with or without addition of platelet-rich plasma is effective in decreasing pain and symptoms in knee osteoarthritis: a controlled, double-blind clinical trial. Knee Surgery Sports Traumatology Arthroscopy 2020;28(6):1989-99. [DOI: 10.1007/s00167-019-05732-8] - DOI - PubMed
Chen 2021 {published data only}
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Emadedin 2018 {published data only}
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Freitag 2019 {published data only}
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Garay‐Mendoza 2018 {published data only}
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Goncars 2017 {published data only}
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Gupta 2016 {published and unpublished data}
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Ho 2022 {published data only}
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Khalifeh Soltani 2019 {published and unpublished data}
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Kim 2023 {published data only}
    1. Kim KI, Lee MC, Lee JH, Moon YW, Lee WS, Lee HJ, et al. Clinical efficacy and safety of the intra-articular injection of autologous adipose-derived mesenchymal stem cells for knee osteoarthritis: a phase III, randomized, double-blind, placebo-controlled trial. American Journal of Sports Medicine 2023;51(9):2243-53. [DOI: 10.1177/03635465231179223] - DOI - PubMed
Kuah 2018 {published data only}
    1. Kuah D, Sivell S, Longworth T, James K, Guermazi A, Cicuttini F, et al. Safety, tolerability and efficacy of intra-articular Progenza in knee osteoarthritis: a randomized double-blind placebo-controlled single ascending dose study. Journal of Translational Medicine 2018;16(1):49. [DOI: 10.1186/s12967-018-1420-z] - DOI - PMC - PubMed
Lamo‐Espinosa 2016 {published data only}
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Lamo‐Espinosa 2020 {published data only}
    1. Lamo-Espinosa JM, Blanco JF, Sánchez M, Moreno V, Granero-Moltó F, Sánchez-Guijo F, et al. Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis. Journal of Translational Medicine 2020;18(1):356. [DOI: 10.1186/s12967-020-02530-6] - DOI - PMC - PubMed
Lee 2019 {published data only}
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Lu 2019 {published data only}
    1. Lu L, Dai C, Zhang Z, Du H, Li S, Ye P, et al. Treatment of knee osteoarthritis with intra-articular injection of autologous adipose-derived mesenchymal progenitor cells: a prospective, randomized, double-blind, active-controlled, phase IIb clinical trial. Stem Cell Research & Therapy 2019;10(1):143. [DOI: 10.1186/s13287-019-1248-3] - DOI - PMC - PubMed
Matas 2019 {published data only}
    1. Espinoza F, Matas J, Orrego M, Tapia R, Infante C, Khoury M, et al. Allogeneic mesenchymal stromal cell (MSC) therapy for knee osteoarthritis (OA): a phase I/II randomized controlled trial. Cytotherapy 2017;19(5):S24.
    1. Matas J, Orrego M, Amenabar D, Infante C, Tapia-Limonchi R, Cadiz MI, et al. Umbilical cord-derived mesenchymal stromal cells (MSCs) for knee osteoarthritis: repeated MSC dosing is superior to a single msc dose and to hyaluronic acid in a controlled randomized phase I/II trial. Stem Cells Translational Medicine 2019;8(3):215-24. [DOI: 10.1002/sctm.18-0053] - DOI - PMC - PubMed
Ren 2023 {published data only}
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Sadat‐Ali 2021 {published data only}
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Sadri 2023 {published data only}
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Shapiro 2017 {published data only}
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Vega 2015 {published and unpublished data}
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Zhang 2022 {published data only}
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References to studies excluded from this review

ACTRN12616001259437 {unpublished data only}
    1. ACTRN12616001259437. A study using non-expanded stem cells for the treatment of early osteoarthritis of the knee (focal chondral defects) in comparison to standard conservative management. https://anzctr.org.au/ACTRN12616001259437.aspx.
Anonymous 2021 {published data only}
    1. Anonymous 2021. Abstracts from the Virtual 2021 OARSI World Congress on Osteoarthritis. Osteoarthritis and Cartilage 2021;29(Suppl 1):S1-S442.
Bastos 2018 {published data only}
    1. Bastos R, Mathias M, Andrade R, Bastos R, Balduino A, Schott V, et al. Intra-articular injections of expanded mesenchymal stem cells with and without addition of platelet-rich plasma are safe and effective for knee osteoarthritis. Knee Surgery Sports Traumatology Arthroscopy 2018;26(11):3342-50. [DOI: 10.1007/s00167-018-4883-9] - DOI - PubMed
Bhattacharya 2011 {published data only}
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Brittberg 2018 {published data only}
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Centeno 2018 {published data only}
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ChiCTR‐ONN‐16009932 {published data only}
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Conaghan 2023 {published data only}
    1. Conaghan P, Wang M, Kim S. Post hoc analyses of 52 week pain responder indices to explore clinically meaningful outcomes after intra-articular tissuegene-c (TG-C): data from a knee osteoarthritis randomized trialpost hoc analyses of 52 week pain responder indices to explore clinically meaningful outcomes after intra-articular tissuegene-c (TG-C): data from a knee osteoarthritis randomized trial. Osteoarthritis and Cartilage 2023;31:S177-8.
CTRI/2010/091/000270 {published data only}
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EUCTR2010‐022072‐31‐GB {published data only}
    1. EUCTR2010-022072-31-GB. A comparison of two different cell types for treating osteoarthritis in the knee. https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2010-022072-31-GB (first received 16 June 2011).
Ha 2018 {published data only}
    1. Ha C, Park Y, Kim J, Rhim J, Kim M, Han W, et al. Allogeneic stem cells versus microfracture for cartilage repair in osteoarthritis. Cytotherapy 2018;20(5):S111-2.
Hernigou 2021 {published data only}
    1. Hernigou P, Delambre J, Quiennec S, Poignard A. Human bone marrow mesenchymal stem cell injection in subchondral lesions of knee osteoarthritis: a prospective randomized study versus contralateral arthroplasty at a mean fifteen year follow-up. International Orthopedics 2021;45(2):365-73. - PubMed
Hong 2019 {published data only}
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ISRCTN13337022 2017 {published data only}
    1. ISRCTN13337022. Osteoarthritis stem cell therapy. http://isrctn.com/ISRCTN13337022 (first received 24 February 2017).
JPRN‐jRCTb032220282 {unpublished data only}
    1. JPRN-jRCTb032220282. Clinical trial on osteoarthritis using spheroid of adipose-derived mesenchymal stem cells. https://trialsearch.who.int/Trial2.aspx?TrialID=JPRN-jRCTb032220282 (first received 19 August 2022).
JPRN‐UMIN000026732 {published data only}
    1. JPRN-UMIN000026732. Intraarticular injections of synovial stem cells for osteoarthritis of the knee. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R0000... (first received 01 June 2017).
Khasru 2023 {published data only}
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NCT02776943 {published data only}
    1. NCT02776943. UCMSC transplantation in the treatment of cartilage damage. clinicaltrials.gov/ct2/show/NCT02776943 (first received 18 May 2016).
NCT02958267 {published data only}
    1. NCT02958267. Investigation of mesenchymal stem cell therapy for the treatment of osteoarthritis of the knee. clinicaltrials.gov/ct2/show/NCT02958267 (first received 8 November 2016).
NCT02963727 {published data only}
    1. NCT02963727. Use of Wharton jelly derived mesenchymal stem cells for knee osteoarthrosis. clinicaltrials.gov/ct2/show/NCT02963727 (first received 15 November 2016).
NCT02966951 {published data only}
    1. NCT02966951. Use of adipose tissue derived mesenchymal stem cells for knee osteoarthrosis. clinicaltrials.gov/ct2/show/NCT02966951 (first received 17 November 2016).
NCT03308006 {published data only}
    1. NCT03308006. Knee osteoarthritis treatment with adipose-derived stem cells: phase II clinical trial. clinicaltrials.gov/ct2/show/NCT03308006 (first received 12 October 2017).
NCT03337243 {published data only}
    1. NCT03337243. Effect of implanting allogenic cytokines derived from human amniotic membrane (HAM) and mesenchymal stem cells derived from human umbilical cord Wharton's jelly HUMCWJ) on pain and functioning of knee osteoarthritis. clinicaltrials.gov/ct2/show/NCT03337243 (first received 8 November 2017).
NCT03602872 {published data only}
    1. NCT03602872. Safety of allogeneic bone marrow derived mesenchymal stem cells in subjects with osteoarthritis. clinicaltrials.gov/ct2/show/NCT03602872 (first received 27 July 2018).
NCT03790189 {published data only}
    1. NCT03790189. Subchondral and intra-articular application of bone marrow concentrate for knee unicompartmental OA (MarrowMule). clinicaltrials.gov/ct2/show/NCT03790189 (first received 31 December 2018).
NCT03956719 {published data only}
    1. NCT03956719. Treatment of early knee osteoarthritis with autologous adipose-derived mesenchymal stem cells. clinicaltrials.gov/ct2/show/NCT03956719 (first received 21 May 2019).
NCT04314661 {unpublished data only}
    1. NCT04314661. Comparative effectiveness of arthroscopy and non-arthroscopy using mesenchymal stem cell therapy (MSCs) and conditioned medium for osteoartrithis. clinicalTrials.gov/show/NCT04314661 (first received 19 March 2020).
NCT04448106 {published data only}
    1. NCT04448106. Autologous adipose tissue-derived mesenchymal stem cells (AdMSCs) for osteoarthritis (AdMSCs). clinicaltrials.gov/ct2/show/NCT04448106 (first received 25 June 2020).
Olufade 2022 {published data only}
    1. Olufade O, Negron G, Berrigan W, Sirutis B, Whitley J, Easley K, et al. Amniotic dehydrated cell and protein concentrate versus corticosteroid in knee osteoarthritis: preliminary findings. Regenerative Medicine 2022;17(7):431-43. - PubMed
Pham 2016 {published data only}
    1. Pham PV. A controlled clinical trial of adipose derived stem cell transplantation for osteoarthritis. Cytotherapy 2016;18(6):S12-3.
Ruane 2021 {published data only}
    1. Ruane JJ, Ross A, Zigmont V, McClure D, Gascon G. A single-blinded randomized controlled trial of mesenchymal stem cell therapy for the treatment of osteoarthritis of the knee with active control. Journal of Stem Cells and Regenerative Medicine 2021;17(1):3-17. - PMC - PubMed
Saris 2022 {published data only}
    1. Saris TF, Windt TS, Custers RJ, Saris DB. Use of allogeneic mesenchymal signaling cells (MSCs) to augment cartilage repair. Operative Techniques in Sports Medicine 2022;30(4):150962.
Sekiya 2021 {published data only}
    1. Sekiya I, Katano H, Mizuno M, Koga H, Masumoto J, Tomita M, et al. Alterations in cartilage quantification before and after injections of mesenchymal stem cells into osteoarthritic knees. Scientific Reports 2021;11(1):13832. - PMC - PubMed
Turajane 2017 {published data only}
    1. Turajane T, Chaweewannakorn U, Aojanepong J, Fongsarun W, Papadopoulos K. Avoidance of total knee arthroplasty in early osteoarthritis of the knee with intra-articular implantation of autologous activated peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial with differential effects of growth factor addition. Cytotherapy 2017;19(5):S228‐9. - PMC - PubMed
Zhao 2019 {published data only}
    1. Zhao X, Ruan J, Tang H, Li J, Shi Y, Li M, et al. Multi-compositional MRI evaluation of repair cartilage in knee osteoarthritis with treatment of allogeneic human adipose-derived mesenchymal progenitor cells. Stem Cell Research & Therapy 2019;10(1):308. - PMC - PubMed

References to studies awaiting assessment

Aghdami 2014 {published data only}
    1. Aghdami N, Ghorbani Liastani M, Emadedin M, Mohseni F, Fazeli R, Moghadasali R, et al. Repeated intra articular injection of bone marrow derived mesenchymal stem cell in knee osteoarthritis: double blind randomized clinical trial. Cytotherapy 2014;16(Suppl 4):S14.
Bakowski 2020 {published data only}
    1. Bąkowski P, Kaszyński J, Wałecka J, Ciemniewska-Gorzela K, Bąkowska-Żywicka K, Piontek T. Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection in the treatment of knee osteoarthritis: a randomized, controlled study - study protocol. BMC Musculoskeletal Disorders 2020;21(1):314. - PMC - PubMed
Dallo 2021 {published data only}
    1. Dallo I, Szwedowski D, Mobasheri A, Irlandini E, Gobbi A. A prospective study comparing leukocyte-poor platelet-rich plasma combined with hyaluronic acid and autologous microfragmented adipose tissue in patients with early knee osteoarthritis. Stem Cells and Development 2021;30(13):651-9. - PubMed
Fiolin 2020 {published data only}
    1. Fiolin J, Dilogo IH, Lubis A, Pawitan JA, Liem IK, Pandelaki J, et al. Functional and radiological comparison of umbilical cord mesenchymal stem cells, somatotropin, and hyaluronic acid injection for cartilage repair in early osteoarthritis of the knee: a randomized controlled trial. Orthopaedic Journal of Sports Medicine 2020;8(5 Suppl 5):2325967120S00045. [DOI: 10.1177/2325967120S00045] - DOI
Jones 2018 {published data only}
    1. Jones IA, Wilson M, Togashi R, Han B, Mircheff AK, Thomas Vangsness C. A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol. BMC Musculoskeletal Disorders 2018;19(1):383. - PMC - PubMed
Khasru 2019 {published data only}
    1. Khasru MR, Salek AM, Marzen T, Siddiq A, Islam M. Peripheral blood derived stem cells in OA knee at low resource setting: a phase II RCT. Osteoarthritis and Cartilage 2019;27(Suppl 1):S512.
    1. Khasru MR. AB0870 Pain and functional outcome of peripheral blood derived stem cells in primary osteoarthritis of knee at low resources setting: a Phase II pilot RCT. Annals of the Rheumatic Diseases 2020;79:1741.
Liang 2015 {published data only}
    1. Liang JJ, He ZY, Liu K, Li XL, Cheng WM, Yu XP, et al. Intraarticular injection of autologous bone marrow mesenchymal stem cells for mild-to-moderate osteoarthritis. Chinese Journal of Tissue Engineering Research 2015;19(14):2216-23.
Maheswari 2022 {published data only}
    1. Maheswari S, Cherian J, Goni V, Sharma A, Tripathy S, Talari K, et al. 268 Allogeneic, off the shelf, bone marrow derived, pooled, mesenchymal stromal cells - a potential break through therapy for grade II & III osteoarthritis knee management. Orthopaedic Journal of Sports Medicine 2022;10:7.
March 2013 {published data only}
    1. March L, Hunter D, Ward C, Smith L, Herbert B, Lilischkis R, et al. A randomised placebo controlled pilot study of autologous non-expanded adipose-derived mesenchymal stem cells in the treatment of knee osteoarthritis. Internal Medicine Journal 2013;43(Suppl 2):4-5.
Nasb 2020 {published data only}
    1. Nasb M, Liangjiang H, Gong C, Hong C. Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial. BMC Musculoskeletal Disorders 2020;21(1):33. - PMC - PubMed
Wang 2016 {published data only}
    1. Wang Y, Jin W, Liu H, Cui Y, Mao Q, Fei Z, et al. Curative effect of human umbilical cord mesenchymal stem cells by intra-articular injection for degenerative knee osteoarthritis. Chinese Journal of Reparative and Reconstructive Surgery 2016;30(12):1472-7. - PubMed
Zi‐Yi 2018 {published data only}
    1. Zi-Yi Y, Jian-Hao L, Dan X, Bin W, Yun-Fei H. Human umbilical cord mesenchymal stem cells in the treatment of knee osteoarthritis: study protocol for a clinical trial. Chinese Journal of Tissue Engineering Research 2018;22(9):1407-12.

References to ongoing studies

ACTRN12611000274976 {published data only}
    1. ACTRN12611000274976. Adipose-derived stem cells in patients with knee osteoarthritis: a randomised controlled trial evaluating pain, function and cartilage repair. anzctr.org.au/ACTRN12611000274976.aspx (first received 15 March 2011).
ACTRN12614001044617 {published data only}
    1. ACTRN12614001044617. A randomised, stratified, placebo-controlled, observer double-blind multicentre proof of concept study of the safety and efficacy of autologous stromal vascular fraction (SVF) with or without platelet rich plasma (PRP) and hyaluronic acid (HA) in patients with osteoarthritis of the knee. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001... (first received 29 September 2014).
ACTRN12617001095358 {unpublished data only}
    1. ACTRN12617001095358. A phase I, randomised, double blind, placebo-controlled, single ascending dose study to evaluate the safety and tolerability of allogeneic adipose-derived mesenchymal stem cells injected into patients with osteoarthritis of the knee. https://anzctr.org.au/ACTRN12617001095358.aspx (first received 27 July 2017).
ChiCTR1800017713 {published data only}
    1. ChiCTR1800017713. A multIcentre, randomized, double blind, controlled trial for safety and efficacy of BL173-hUMSCs in the treatment of osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR1800017713 (first received 10 August 2018).
ChiCTR1900025685 {unpublished data only}
    1. ChiCTR1900025685. The clinical research for efficacy and safety of intra-articular injection of autologous adipose-derived stem cell combined with platelet rich plasma for the treatment of degenerative osteoarthritis articular cartilage defects of the knee. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR1900025685 (first received 05 September 2019).
ChiCTR1900025907 {published data only}
    1. ChiCTR1900025907. Stem cells, low intensity pulsed ultrasound or their combination for the treatment of knee osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR1900025907 (first received 14 September 2019).
ChiCTR2000033408 {published data only}
    1. ChiCTR2000033408. Clinical study on the efficacy and safety of human umbilical cord mesenchymal stem cells in the treatment of osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2000033408 (first received 31 May 2020).
ChiCTR2000039017 {unpublished data only}
    1. ChiCTR2000039017. Clinical study of human umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of knee osteoarthritis. http://www.chictr.org.cn/showproj.aspx?proj=62498 (first received 13 October 2020).
ChiCTR2100041683 {published data only}
    1. ChiCTR2100041683. Human umbilical cord mesenchymal stem cells treating knee osteoarthritis: a randomized, double-blind, controlled clinical study. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100041683 (first received 01 January 2021).
ChiCTR2100045261 {published data only}
    1. ChiCTR2100045261. Short-term clinical efficacy of autologous stem cell injection versus physical therapy for inflammatory knee osteoarthritis: a randomized controlled trial. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100045261 (first received 10 April 2021).
ChiCTR2100047124 {published data only}
    1. ChiCTR2100047124. Comparing the effects of stem cells and rehabilitation therapy for the treatment of knee osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100047124 (first received 08 June 2021).
ChiCTR‐INR‐17014226 {unpublished data only}
    1. ChiCTR-INR-17014226. A randomized, single blind clinical study of human umbilical cord mesenchymal stem cells compare sodium hyaluronate to treatment of early osteoarthritis of the knee. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-INR-17014226 (first received 30 December 2017).
ChiCTR‐IOR‐15006942 {published data only}
    1. ChiCTR-IOR-15006942. RCT mesenchymal stem cells versus hyaluronic acid in OA knee. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-IOR-15006942 (first received 20 August 2015).
ChiCTR‐OCN‐15006356 {published data only}
    1. ChiCTR-OCN-15006356. The effect of injecting the peripheral blood stem cell and platelet rich plasma into articular cavity combined oral Chinese medicine to treat knee osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-OCN-15006356 (first received 6 May 2015).
CTRI/2009/091/000435 {published data only}
    1. CTRI/2009/091/000435. A controlled study with allogenic mesenchymal stem cells in patients with osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2009/091/000435 (first received 3 July 2009).
CTRI/2011/07/001891 {published data only}
    1. CTRI/2011/07/001891. A clinical trial to study the effect of different doses of stem cells in osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2011/07/001891 (first received 18 July 2011).
EUCTR2019‐002446‐21 {unpublished data only}
    1. EUCTR2019-002446-21. Phase III, multicentre, randomized, open clinical trial comparing treatment with allogenic mesenchymal cells against autologous mesenchymal cells and against active control with hyaluronic acid in patients with knee osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2019-002446-21-ES (first received 10 January 2020).
EUCTR2019‐005000‐17‐PL {published data only}
    1. EUCTR2019-005000-17-PL. A randomized, double blind, two arms, controlled phase I/II safety and efficacy study on MesoCellA-Ortho tissue engineered product intraarticularly administrated in adult patients with osteoarthrosis. https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2019-005000-17-PL (first received 15 July 2021).
IRCT20080728001031N23 {unpublished data only}
    1. IRCT20080728001031N23. Allogeneic stem cell transplantation in knee joint osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20080728001031N23 (first received 24 April 2018).
IRCT2012080510507N1 {published data only}
    1. IRCT2012080510507N1. Evaluation of efficacy of treatment with stem cells (SCs) and platelet-rich plasma (PRP) in patients with knee arthrosis. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT2012080510507N1 (first received 1 June 2014).
IRCT20151017024572N19 {published data only}
    1. IRCT20151017024572N19. Effect of mesenchimal stem cell in knee osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20151017024572N19 (first received 5 January 2019).
IRCT2016021710507N4 {published data only}
    1. IRCT2016021710507N4. Evaluation of effectiveness of intra-articular injection of stem cells on knee arthrosis. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT2016021710507N4 (first received 20 February 2016).
IRCT20210103049925N1 {published data only}
    1. IRCT20210103049925N1. The effect of mesenchymal stem cells on osteoarthritis recovery. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20210103049925N1 (first received 20 May 2021).
IRCT20210307050611N1 {published data only}
    1. IRCT20210307050611N1. Mesenchymal stem cell injection in patients with knee osteoarthritis compared to a randomized controlled trial. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20210307050611N1 (first received 22 May 2021).
IRCT20210423051054N1 {unpublished data only}
    1. IRCT. Evaluation of therapeutic effect of placental mesenchymal stem cell exosome injection in improving clinical symptoms and MRI changes in patients with knee osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20210423051054N1 (first received 11 May 2022).
IRCT20211102052944N1 {published data only}
    1. IRCT20211102052944N1. Intra-articular transplantation of umbilical cord stromal mesenchymal cells in patients with knee osteoarthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20211102052944N1 (first received 09 November 2021).
ISRCTN88966184 {unpublished data only}
    1. ISRCTN88966184. Personalized treatment of knee osteoarthritis with fat tissue containing stem cells. https://www.isrctn.com/ISRCTN88966184 (first received 1 August 2022).
KCT0001619 {published data only}
    1. KCT0001619. Multicenter, randomized, double-blind, placebo controlled phase IIb/III clinical trial to evaluate efficacy and safety of JOINTSTEM in patients with degenerative arthritis. https://trialsearch.who.int/Trial2.aspx?TrialID=KCT0001619 (first received 08 September 2015).
Liu 2021 {published data only}
    1. Liu X, Robbins S, Wang X, Virk S, Schuck K, Deveza LA, et al. Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial). BMJ Open 2021;11(11):e056382. [DOI: 10.1136/bmjopen-2021-056382] [ACTRN12620000870954] - DOI - PMC - PubMed
Mikkelsen 2021 {published data only}
    1. Mikkelsen RK, Blønd L, Hölmich LR, Mølgaard C, Troelsen A, Hülmich P, et al. Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial. Trials 2021;22:748. [DOI: 10.1186/s13063-021-05628-4] - DOI - PMC - PubMed
NCT01448434 {published data only}
    1. NCT01448434. Allogeneic mesenchymal stem cells for osteoarthritis. https://clinicaltrials.gov/show/NCT01448434 (first received 20 September 2011).
NCT01459640 {unpublished data only}
    1. NCT01459640. Intra-articular autologous bone marrow mesenchymal stem cells transplantation to treat mild to moderate osteoarthritis. https://clinicaltrials.gov/study/NCT01459640 (first received 24 October 2011).
NCT01985633 {published data only}
    1. NCT01985633. Mesenchymal stem cells enhanced with PRP versus PRP in OA knee (MSCPRPOAK). https://clinicaltrials.gov/ct2/show/NCT01985633 (first received 05 November 2013).
NCT02674399 {published data only}
    1. NCT02674399. A phase 2 study to evaluate the efficacy and safety of JointStem in treatment of osteoarthritis. https://clinicaltrials.gov/show/NCT02674399 (first received 02 February 2016).
NCT02784964 {published data only}
    1. NCT02784964. Adipose-derived stem cells (ADSCs) for knee osteoarthritis. https://clinicaltrials.gov/show/NCT02784964 (first received 16 May 2016).
NCT03028428 {published data only}
    1. NCT03028428. Intra-articular injection of MSCs in treatment of knee OA. https://clinicaltrials.gov/ct2/show/NCT03028428 (first received 20 January 2017).
NCT03164083 {published data only}
    1. NCT03164083. The effects of stromal vascular fraction and mesenchymal stem cells as intra-articular injection in knee joint osteoarthritis. https://clinicaltrials.gov/show/NCT03164083 (first received 21 May 2017).
NCT03166865 {published data only}
    1. NCT03166865. Clinical study of umbilical cord mesenchymal stem cells (UC-MSC) for treatment of knee osteoarthritis. https://clinicaltrials.gov/show/NCT03166865 (first received 23 May 2017).
NCT03271229 {published data only}
    1. NCT03271229. Conventional platelet-rich plasma versus concentrated bone marrow stem cell injections for osteoarthritis of the knee. https://clinicaltrials.gov/show/NCT03271229 (first received 31 August 2017).
NCT03357575 {published data only}
    1. NCT03357575. The comparison of efficacy and safety of the mesenchymal stem cells from adipose and hyaluronic acid. https://clinicaltrials.gov/show/NCT03357575 (first received 16 December 2017).
NCT03379168 {published data only}
    1. NCT03379168. Efficacy of micro-fragmented adipose tissue injection for knee osteoarthritis. https://clinicaltrials.gov/show/NCT03379168 (first received 07 December 2017).
NCT03383081 {published data only}
    1. NCT03383081. The safety/efficacy of human umbilical cord mesenchymal stem cells (19#iSCLife®-OA) therapy for patients with osteoarthritis. https://clinicaltrials.gov/ct2/show/NCT03383081 (first received 12 December 2017).
NCT03467919 {published data only}
    1. NCT03467919. The effect of micro fragmented adipose tissue (MFAT) on knee osteoarthritis. https://clinicaltrials.gov/ct2/show/NCT03467919 (first received 20 December 2017).
NCT03800810 {published data only}
    1. NCT03800810. Implantation of allogenic mesenchymal stem cell from umbilical cord blood for osteoarthritis management. https://clinicaltrials.gov/ct2/show/results/NCT03800810 (first received 02 July 2018).
NCT03818737 {published data only}
    1. NCT03818737. Multicenter trial of stem cell therapy for osteoarthritis (MILES) MILES. https://clinicaltrials.gov/ct2/show/NCT03818737 (first received 24 January 2019).
NCT03825133 {unpublished data only}
    1. NCT03825133. The comparison of knee osteoarthritis treatment with bone marrow aspirate concentrate, leukocyte rich platelet rich plasma and hyaluronic acid. https://clinicaltrials.gov/show/NCT03825133 (first received 23 January 2019).
NCT03908827 {published data only}
    1. NCT03908827. BMAC in severe hip or knee osteoarthritis awaiting arthroplasty. https://clinicaltrials.gov/show/NCT03908827 (first received 07 April 2019).
NCT03943576 {published data only}
    1. NCT03943576. Allogeneic adipose tissue-derived mesenchymal stem cells (GXCPC1) for knee osteoarthritis. https://clinicaltrials.gov/show/NCT03943576 (first received 23 January 2019).
NCT03969680 {unpublished data only}
    1. NCT03969680. Autologous mesenchymal stem cell transplantation for the treatment of knee osteoarthritis. https://clinicaltrials.gov/study/NCT03969680 (first received 29 May 2019).
NCT03975101 {unpublished data only}
    1. NCT03975101. Very small embryonic-like stem cells for knee osteoarthritis. https://clinicaltrials.gov/show/NCT03975101 (first received 31 May 2019).
NCT03990805 {published data only}
    1. NCT03990805. A phase 3 study to evaluate the efficacy and safety of jointstem in treatment of osteoarthritis. https://clinicaltrials.gov/show/NCT03990805 (first received 13 June 2019).
NCT04130100 {published data only}
    1. NCT04130100. Clinical study of pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis. https://clinicaltrials.gov/show/NCT04130100 (first received 11 October 2019).
NCT04208646 {published data only}
    1. NCT04208646. Allogenic adipose tissue-derived mesenchymal progenitor cells for the treatment of knee osteoarthritis. https://clinicaltrials.gov/ct2/show/NCT04208646 (first received 17 December 2019).
NCT04212728 {published data only}
    1. NCT04212728. Treatment of knee osteoarthritis with autologous adipose-derived mesenchymal stem cells. https://clinicaltrials.gov/show/NCT04212728 (first received 26 December 2019).
NCT04230902 {published data only}
    1. NCT04230902. Effects of a MAT versus steroid injection in knee osteoarthritis (STa MAT-knee Study). https://clinicaltrials.gov/show/NCT04230902 (first received 29 January 2019).
NCT04240873 {published data only}
    1. NCT04240873. Clinical study of intra articular injection of catholic MASTER cell (bone marrow derived mesenchymal stem cell) in knee osteoarthritis MSC-OA. https://clinicaltrials.gov/show/NCT04240873 (first received 10 December 2019).
NCT04326985 {unpublished data only}
    1. NCT04326985. RCT mesenchymal stem cells versus hyaluronic acid in OA knee: MSC. https://clinicaltrials.gov/show/NCT04326985 (first received 27 March 2020).
NCT04368806 {unpublished data only}
    1. NCT04368806. A phase 2b/3a study to evaluate the efficacy and safety of JointStem in patients diagnosed as knee osteoarthritis. https://clinicaltrials.gov/ct2/show/NCT04368806 (first received 21 April 2020).
NCT04520945 {published data only}
    1. NCT04520945. Phase 2B clinical study of chondrogen for treatment of knee osteoarthritis. https://clinicaltrials.gov/show/NCT04520945 (first received 17 August 2020).
NCT04821102 {published data only}
    1. NCT04821102. Investigator initiated trial to evaluate cartilage regeneration by arthroscopy after JOINTSTEM administration. https://clinicaltrials.gov/show/NCT04821102 (first received 24 March 2021).
NCT04863183 {unpublished data only}
    1. NCT04863183. Cell therapy with cellistem-OA for symptomatic knee osteoarthritis. https://clinicaltrials.gov/show/NCT04863183 (first received 20 April 2021).
NCT05027581 {unpublished data only}
    1. NCT05027581. Chondrochymal® for subjects with knee osteoarthritis (knee OA). https://clinicaltrials.gov/show/NCT05027581 (first received 19 August 2021).
NCT05081921 {unpublished data only}
    1. NCT05081921. Clinical trial to evaluate safety and efficacy of MesoCellA-Ortho tissue-engineered advanced therapy product in patients with osteoarthrosis and civilisation diseases (BioMiStem-CT). https://clinicaltrials.gov/show/NCT05081921 (first received 15 July 2021).
NCT05086939 {unpublished data only}
    1. NCT05086939. Multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis. ARTROCELL. https://clinicaltrials.gov/show/NCT05086939 (first received 05 July 2021).
NCT05182034 {unpublished data only}
    1. NCT05182034. Clinical trial to evaluate efficacy and safety of SMUP-IA-01 in patients with knee osteoarthritis. https://clinicaltrials.gov/show/NCT05182034 (first received 12 December 2021).
NCT05193877 {unpublished data only}
    1. NCT05193877. Autologous bone marrow aspirate concentrate injection for the treatment of early osteoarthritis: Baghdad 2022. https://clinicaltrials.gov/show/NCT05193877 (first received 24 December 2021).
NCT05288725 {unpublished data only}
    1. NCT05288725. Mesenchymal stem cell therapy for knee osteoarthritis. https://clinicaltrials.gov/show/NCT05288725 (first received 15 February 2022).
NCT05526001 {unpublished data only}
    1. NCT05526001. Efficacy and safety of ELIXCYTE intra-articular injection in subject with knee osteoarthritis. https://clinicaltrials.gov/show/NCT05526001 (first received 28 August 2022).
NCT05579665 {unpublished data only}
    1. NCT05579665. Effectiveness of PRP, conditioned medium UC-MSCs secretome and hyaluronic acid for the treatment of knee osteoarthritis. https://clinicaltrials.gov/ct2/show/NCT05579665 (first received 04 October 2022).
NCT05660824 {unpublished data only}
    1. NCT05660824. Effectiveness of stromal vascular fraction (SVF) and platelets rich plasma (PRP) in osteoarthritis and tendinopathy (SPOT). https://clinicaltrials.gov/show/NCT05660824 (first received 24 January 2022).
NCT05783154 {unpublished data only}
    1. NCT05783154. Effect of mesenchymal stem cells in primary knee osteoarthritis. https://clinicaltrials.gov/show/NCT05783154 (first received 03 February 2023).
NCT05933434 {unpublished data only}
    1. NCT05933434. Allogenic mesenchymal stem cell intraarticular injection for knee osteoarthritis therapy (STEMJOINT). https://clinicaltrials.gov/show/NCT05933434 (first received 05 June 2023).
NCT05936060 {unpublished data only}
    1. NCT05936060. Cartilage recovery in adults with knee osteorthritis by mesenchymal cell therapy: randomized trial of radiologic and clinical outcomes (INMUNOCEM-OA). https://clinicaltrials.gov/study/NCT05936060 (first received 16 June 2023).
NCT05996224 {unpublished data only}
    1. NCT05996224. Allogenic adipose-derived mesenchymal progenitor cells for the treatment of knee osteoarthritis. https://clinicaltrials.gov/ct2/show/NCT05996224 (first received 08 May 2023).
NCT06084637 {published data only}
    1. NCT06084637. Comparison between intra-articular infiltrations of PRP, MFAT, and PRP-MFAT in the treatment of symptomatic knee osteoarthritis. https://clinicaltrials.gov/ct2/show/NCT06084637 (first received 10 October 2023).
RBR‐7qjcdd {unpublished data only}
    1. RBR-7qjcdd. START Trial: randomized, controlled, open and parellel trial to evaluate the efficiency and safety of intra-articular infiltration of autologous bone marrow concentrate (BMC) or mesenchymal stem cell (MSC) associated with platelet rich plasma (PRP) in patients with primary knee osteoarthritis. http://ensaiosclinicos.gov.br/rg/RBR-7qjcdd (first received 07 June 2019).
TCTR20230929002 {unpublished data only}
    1. TCTR20230929002. A comparative study between adipocyte-derived mesenchymal stem cell versus intra-articular hyaluronic acid interventions in early osteoarthritis: prospective randomized open, blinded end-point. www.thaiclinicaltrials.org/show/TCTR20230929002 (first received 29 September 2023).

Additional references

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References to other published versions of this review

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