Randomized, blinded clinical study evaluating injectable autologous hair follicle secretome in patients with androgenic alopecia
TORONTO, ON, CANADA, January 29, 2026 /EINPresswire.com/ — Acorn Biolabs, a regenerative medicine company delivering personalized treatments derived from stem-cell-rich hair follicles, announced today that the first patients have been treated for androgenic alopecia in the clinical evaluation of injectable secretome (YOU™).
The blinded, randomized, controlled trial (NCT07107841) will assess changes in hair density and thickness, investigator and patient global assessments, and safety outcomes over a defined treatment and follow-up period. Patients will be randomized to receive either autologous hair follicle secretome or a placebo in a blinded fashion, enabling robust evaluation of treatment effect and tolerability. The treatment of the first set of patients marks an important milestone toward generating high-quality clinical data in this emerging therapeutic area.
The study will be conducted at a single investigational site in California, Ziering Medical, led by Dr. Craig Ziering, a board-certified celebrity hair transplant surgeon and pioneer in hair transplantation with over 28,000 surgeries performed to date.
“Treating the first patients in this trial is an exciting moment in our path to bringing an autologous injectable regenerative solution to people living with androgenic alopecia,” said Dr. Drew Taylor, CEO at Acorn Biolabs. “This study is another step forward in our mission to build an autologous platform, leveraging a patient’s own biology, to deliver the next generation of regenerative medicine.
“We see substantial and growing interest from patients and clinicians in new, evidence-based options for hair loss,” added Dr. Craig Ziering, principal investigator of the study. “The blinded, randomized, controlled design is critical to understanding both the efficacy and safety profile of this innovative and truly personalized treatment.”
ABOUT YOU™
Autologous hair follicle secretome (YOU™) is a lyophilized powder of growth factors, cytokines, exosomes, and signaling molecules released by a patient’s own follicle-derived stem cells. The bioactive factors identified in YOU™ have demonstrated effects that prolong the anagen (growth) phase, reduce hair follicle miniaturization, and support a healthier cellular environment in the scalp, all of which are relevant to androgenic alopecia. YOU™ and these bioactive factors are currently under evaluation for their potential effects on hair follicle health, preventing hair loss, and restoring hair quality. Because the secretome is autologous—derived from each individual patient—it offers advantages such as reduced immunogenicity and a safety profile distinct from allogeneic or synthetic approaches. Growing interest in personalized regenerative strategies positions YOU™ as a promising option.
UNMET NEED IN ANDROGENIC ALOPECIA
Androgenic alopecia affects a large proportion of the adult population and can significantly impact self- esteem and quality of life, yet currently approved pharmacologic options remain limited and often require long-term, continuous use. Many patients seek regenerative or minimally invasive interventions that can offer durable improvements in hair density with acceptable safety and convenience.
Randomized, controlled clinical trials are essential to determine whether autologous hair follicle secretome can deliver clinically meaningful benefits beyond placebo or standard care. By incorporating objective hair measurements and patient-reported outcomes, this study aims to generate data that are relevant both scientifically and from a patient perspective. The study is being conducted under institutional review board committee oversight and in accordance with Good Clinical Practice and applicable regulatory requirements. Enrollment is ongoing.
ABOUT ACORN BIOLABS
Acorn Biolabs is a regenerative medicine company focused on preserving patients’ own hair follicle stem cells and translating that biology into personalized products for skin and hair, with broader regenerative applications under active research. For more information about this study or Acorn Biolabs, please visit https://acorn.me/
Dave Elliott
Acorn Biolabs
+1 416-828-6141
dave.elliott@acorn.me
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