Clinical Use of Extracellular Vesicles in the Management of Male and Female Pattern Hair Loss: A Preliminary Retrospective Institutional Review Board Safety and Efficacy Study

Abstract

Background Pattern hair loss is a common disorder in female and male subjects that may benefit from the use of cell-free XoFlo (Direct Biologics, LLC, Austin, TX) therapy. Objectives To assess the safety, efficacy and satisfaction of a single extracellular vesicle (EV) treatment over 6 months. Methods A retrospective open-label study among 22 female and 9 male subjects who demonstrated early stages of alopecia or were in remission from prior medical and surgical treatments. The amount of undiluted or diluted volumes of EV solution used was determined by extent and degree of alopecia. Global photography, SGAIS and IGAIS questionnaires, and trichoscan measurements were compared at baseline and six months in three response categories. Results Frequent growth responses were observed: older aged females and younger aged males, shorter history of alopecia; earlier stages of hair loss; larger and undiluted volumes of XoFlo; prior positive responses to medical and surgical treatments; and absence or control of disease factors affecting hair. The benefit of micro-needling to therapy was indeterminate. Global photography, trichoscan for density, follicle diameter, terminal: vellus ratio, and SGAIS/IGAIS satisfaction questionnaires at baseline and six months were useful in assessing clinical efficacy. No significant adverse reactions were observed. Conclusions Intradermal injections with varying doses of EVs were safe and effective among indicated alopecic female and male subjects. Findings suggest that the presence of positive factors, absence of conditions known to negatively affect hair growth, and administration of larger volumes of XoFlo may have a significant influence on the use of this new cell-free therapy. FDA-approved biologic, multi-centered IRB/ Investigational New Drug (IND) trials are clearly required to determine its future in the management of hair loss.

Systematic review of exosome treatment in hair restoration: Preliminary evidence, safety, and future directions

“…Nonetheless, these results corroborated the findings of another case series study using intradermal biologic injection containing EVs 26 . After one course of treatment, 64.5% (20/31) of patients reported hair growth at follow‐up; trichoscan assessment in 11 responders showed an increase in hair density between 11.1% and 24.2% 26 . However, the effects observed in this study can not be attributed to the exosome fraction as the patients had received injections containing a mixture of EVs.…”

“…Patients were administered 2 or 5 mL of undiluted solutions or up to 8 mL of diluted solutions (1:2–1:5) at alopecic scalp regions 26 . During follow‐up, adverse reactions including fever, myalgias, chills, fatigue, or scalp cellulitis were not reported 26 …”

“…26 After one course of treatment, 64.5% (20/31) of patients reported hair growth at follow-up; trichoscan assessment in 11 responders showed an increase in hair density between 11.1% and 24.2%. 26 However, the effects observed in this study can not be attributed to the exosome fraction as the patients had received injections containing a mixture of EVs. Another open-label, singlearm study examining the effects of placental mesenchymal cellderived exosomes in alopecia patients is ongoing (Clini calTr ials.gov; NCT05658094).…”

“…27 The safety of subcutaneous injections was assessed in a case series of 31 AGA patients who received biologic treatment derived from human bone marrow mesenchymal stem cells (MSCs), which contains a mixture of EVs in addition to exosomes. 26 TA B L E 1 (Continued) administered 2 or 5 mL of undiluted solutions or up to 8 mL of diluted solutions (1:2-1:5) at alopecic scalp regions. 26 During follow-up, adverse reactions including fever, myalgias, chills, fatigue, or scalp cellulitis were not reported.…”

“…26 TA B L E 1 (Continued) administered 2 or 5 mL of undiluted solutions or up to 8 mL of diluted solutions (1:2-1:5) at alopecic scalp regions. 26 During follow-up, adverse reactions including fever, myalgias, chills, fatigue, or scalp cellulitis were not reported. 26 A recent study performed safety evaluation of exosomes using in vitro and in vivo models.…”