Long-Term Follow-up of Autologous Fibroblast Transplantation for Facial Contour Deformities, A Non-Randomized Phase IIa Clinical Trial


Amir Bajouri, M.D, 1,#Zahra Orouji, M.D, 1,#Ehsan Taghiabadi, M.Sc, 1,#Abdoreza Nazari, M.Sc, 1Atefeh Shahbazi, M.Sc, 1Nasrin Fallah, M.Sc., 1Parvaneh Mohammadi, Ph.D., 1Mohammad Rezvani, M.D., 1Zahra Jouyandeh, M.D., 1Fatemeh Vaezirad, B.Sc., 1Zahra Khalajasadi, B.Sc., 1Mahshid Ghasemi, M.D., 1Aslan Fanni, M.Sc., 1Sara Haji Hosseinali, M.Sc., 1Ahad Alizadeh, M.Sc., 2Hossein Baharvand, Ph.D., 1Saeed Shafieyan, M.D., 1,*Nasser Aghdami, M.D., Ph.D., 1,*
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
*Corresponding Address: P.O.Box: 16635-148 Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell Biology and Technology ACECR Tehran Iran Emails:sshafiiyan@yahoo.com,nasser.aghdami@royaninstitute.org

The first three authors equally contributed to this work.

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Abstract

Objective

Recently, the promising potential of fibroblast transplantation has become a novel modality for skin rejuvenation. We investigated the long-term safety and efficacy of autologous fibroblast transplantation for participants with mild to severe facial contour deformities.

Materials and Methods

In this open-label, single-arm phase IIa clinical trial, a total of 57 participants with wrinkles (n=37, 132 treatment sites) or acne scars (n=20, 36 treatment sites) who had an evaluator’s assessment score of at least 2 out 7 (based on a standard photo-guide scoring) received 3 injections of autologous cultured fibroblasts administered at 4-6 week intervals. Efficacy evaluations were performed at 2, 6, 12, and 24 months after the final injection based on evaluator and patient’s assessment scores.

Results

Our study showed a mean improvement of 2 scores in the wrinkle and acne scar treatment sites. At sixth months after transplantation, 90.1% of the wrinkle sites and 86.1% of the acne scar sites showed at least a one grade improvement on evaluator assessments. We also observed at least a 2-grade improvement in 56.1% of the wrinkle sites and 63.9% of the acne scar sites. A total of 70.5% of wrinkle sites and 72.2% of acne scar sites were scored as good or excellent on patient assessments. The efficacy outcomes remained stable up to 24-month. We did not observe any serious adverse events during the study.

Conclusion

These results have shown that autologous fibroblast transplantation could be a promising remodeling modality with long-term corrective ability and minimal adverse events (Registration Number: NCT01115634).