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Clinical Trial
. 2022 Jun 27:15:1157-1173.
doi: 10.2147/CCID.S357810. eCollection 2022.

Cell-Free Blood Cell Secretome (BCS) Counteracts Skin Aging: Multi-Center Prospective Regenerative Aesthetic Medicine Study Using Exokine®

Martina Kerscher  1 , Sylvia Wagner-Schiffler  2 , Ernst Magnus Noah  3 , Tanja Fischer  4 , Daniela Greiner-Krüger  5 , Sonja Sattler  6 , Tanju Kaptan  7 , Attyla Drabik  8 , Glyn Hamed  9 , Julio Reinecke  7 , Jana Wehling  10
Affiliations
Clinical Trial

Cell-Free Blood Cell Secretome (BCS) Counteracts Skin Aging: Multi-Center Prospective Regenerative Aesthetic Medicine Study Using Exokine®

Martina Kerscher et al. Clin Cosmet Investig Dermatol. .

Abstract

Background: The "Inflammation Theory of Ageing" identifies pro-inflammatory cytokines and oxidative damage as one cause of cellular and mitochondrial deterioration and aging. Cell-free blood cell secretome (BCS) also known as autologous conditioned serum (ACS) has shown anti-inflammatory and regenerative mode of action in musculoskeletal disorders and radicular compression.

Aim: To confirm that BCS can improve signs of skin aging from a previous study in a multi-center setting.

Methods: Prospective, one-armed, multi-center interventional therapeutic study. Ninety-five women with skin firmness loss were treated with four intra-dermal injection sessions in both cheeks at 0, 2, 4 and 6 weeks. BCS was processed with Exokine® medical device according to manufacturer's instructions. Primary endpoints were cutometric R0 and R3 at 12 and 24 weeks. GAIS, FACE-QTM, Patient Attractivity Self-Assessment and safety were evaluated.

Results: Mean skin firmness (R0) improved significantly from baseline 0.40 mm to 0.38 mm at week 12 and to 0.36 mm at week 24. Mean skin tiring (R3) improved significantly from baseline 0.45 mm to 0.42 mm at week 12 and to 0.40 at week 24. FACE-QTM "Satisfaction with Skin" significantly improved from baseline to weeks 12, 24 and 48. So did "Satisfaction with Facial Appearance" and "Psychological and Social Function". "Satisfaction with Decision" and "Satisfaction with Outcome" were stable at week 24 and 48. At week 48 patients assessed their age 1.68 years younger vs Baseline. FACE-QTM aging appraisal improves from Baseline 52.94 to 65.23 at week 48. GAIS, by both physicians and patients, confirm improvement of skin.

Conclusion: For up to 48 weeks four intra-dermal injections with cell-free BCS increase facial skin firmness and resilience to tiring and patients' satisfaction with their facial appearance and skin. Patients perceive their face as younger. BCS has the ability to sustainably rejuvenate facial skin safely.

Study registration: Registration on German clinical trials register: DRKS00013014.

Keywords: ACS; BCS; autologous; autologous conditioned serum; cell-free blood cell secretome; regeneration; rejuvenation; skin quality.

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Conflict of interest statement

Prof. Dr. Martina Kerscher reports personal fees and study support by providing study materials from Orthogen, during the conduct of the study. Dr Tanja Fischer reports grants from Orthogen, during the conduct of the study. Dr Tanju Kaptan was an Employee of Orthogen AG. Dr Glyn Hamed reports personal fees from Orthogen AG, during the writing of the manuscript and outside the submitted work. Dr Julio Reinecke is an employee of Orthogen, outside the submitted work; In addition, Dr Julio Reinecke shares a patent WO2017080669A1 pending to Orthogen AG. The other authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
A timeline with all interventions and the timepoints at which questionnaires were requested.
Figure 2
Figure 2
Graphics modified and reproduced with friendly permission by Courage+Khazaka GmbH, Cologne, Germany. R0 is the maximum skin extension at the first cycle of applied vacuum. R3 is the maximum skin extension at the last cycle of applied vacuum. In this study 13 cycles were applied to generate the R3 value. R9 is not used in this manuscript, it is R3–R0, the net tiring value in mm.
Figure 3
Figure 3
Skin firmness (R0) and Skin tiring (R3) recorded at weeks 12, 24 and 48 show significant improvement vs baseline. R0 and R3 are highly significant at week 24 with ***p < 0.001 compared to baseline. Week 12 shows significance with *p < 0.05 for R0 and significance with **p < 0.01 for R3. Week 48 shows significance with **p < 0.01 for R0 and ***p < 0.001 for R3. Table S1 provides the full data set.
Figure 4
Figure 4
FACE-QTM Data evaluated by questionnaire “Satisfaction with skin” was assessed at Baseline, week 12, 24 and 48. Figure 4 shows change from baseline. Week 12 shows 20.2, week 24 shows 14.6 and week 48 shows 14.4 score points improvement vs baseline. Statistical significance at all timepoints: *** p < 0.001. Table S2 in the supplementary Document provides the full data set.
Figure 5
Figure 5
Patient-perceived age at week 24 and 48. Displayed is the difference to perceived age in years at Baseline. ***p < 0.0001.
Figure 6
Figure 6
GAIS score assessed by physician at week 6, 12, 24 and 48. Week 6, 12, and 24 show high significance with ***p < 0.001. One physician scored one patient as “worse”.
Figure 7
Figure 7
GAIS score assessed by patient at week 6, 12, 24 and 48. All time points show high significance with ***p < 0.001. No patient scored herself as “worse”.
Figure 8
Figure 8
Self assessed attractiveness improved significantly when compared to baseline with **p < 0.01 at week 12 and ***p < 0.001 at week 48. Table S7 in the supplementary document shows all numbers analyzed.
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