Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05659095 |
| Other study ID # |
NFEC-2020-245 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
January 1, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Nanfang Hospital of Southern Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
