Autologous Hair Follicle Derived Mesenchymal Stem Cell Suspension to Treat AGA
Condition: Hair Transplantation
Study type: Interventional

Summary: 
      Androgenic alopecia (AGA) is characterized by progressive hair follicle miniaturization, and
      novel treatments are needed to intervene in the miniaturization process. The investigators
      aimed to evaluate the efficacy, safety, effectiveness, and effective population of autologous
      hair follicle mesenchymal stem cell therapy for the treatment of advanced AGA in Chinese
      people.

      50 participants ranging from 25 to 45 years old, with an average age of 32 ± 1.24 years were
      included. None of them had ever used minoxidil, finasteride, or other drugs to promote hair
      growth. Healthy hair follicles were extracted from the occipital area and treated to obtain
      hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two
      groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1
      × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months.
      Observers were blinded to patient groupings and measurements.
    

Detailed description: 
      Androgenic alopecia (AGA) is the most common form of hair loss. It starts in adolescence and
      is mainly characterized by progressive hair follicle miniaturization. In the continuous hair
      cycle process, the pathological hair follicle mesenchymal niche in the hair loss area is
      continuously damaged. The mesenchymal cells are continuously consumed, resulting in
      functional disorder, gradually losing the ability to induce the proliferation and
      differentiation of hair follicle epidermal cells to form hair follicles. This process
      eventually leads to the complete miniaturization and loss of hair follicles. Presently,
      non-surgical treatments for AGA, such as minoxidil or finasteride, have great individual
      differences in the effectiveness in different populations and may not achieve the expected
      effect of patients with advanced AGA, although they are still recommended as first-line drugs
      for androgenic alopecia.

      Hair follicle mesenchymal stem cells (HF-MSCs) included dermal papilla cells (DPCs) and
      dermal sheath cells (DSCs). Similar to other types of mesenchymal stem cells, HF-MSCs possess
      stem cell characteristics such as multidirectional differentiation potential, the ability of
      integrated homing to a specific niche, and secretion of exosomes and cytokines, which have
      great application prospects. HF-MSCs are considered an important therapeutic agent to promote
      hair growth. A previous study has indicated that injection of DPC spheres can promote hair
      growth on the back of mice. A double-blind clinical trial in Japan confirmed that treatment
      of the expanded dermal sheath cup cells (DSCCs) of healthy human hair follicles could promote
      the growth of hair follicles in the hair loss area of the forehead. However, the population
      and stage of AGA for which HF-MSC therapy is effective have not yet been reported. The
      investigators conducted a randomized clinical trial, extracted hair follicles from the human
      occipital area, prepared an HF-MSC suspension and locally injected it into the forehead hair
      loss area. Through follow-up observations, this study aimed to evaluate the safety and
      effectiveness of autologous hair follicle mesenchymal stem cell therapy in the treatment of
      AGA. The investigators expounded the possible effective population and stage.
    

Intervention name(s): autologous hair follicle derived mesenchymal stem cell suspension
Intervention type(s): Other
Intervention description(s): Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic