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Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia

Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia: A Randomized, Double-blind Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05296863
Enrollment
37
Registered
2022-03-25
Start date
2021-10-11
Completion date
2021-12-03
Last updated
2022-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia, Androgenetic, Hair Loss/Baldness

Keywords

Stem cell therapy, Adipose derived stem cell conditioned media, Hair regeneration

Brief summary

This study investigated the efficacy of adipose derived stem cell conditioned media (ADSC-CM) combined with minoxidil for hair regeneration therapy in male AGA.

Detailed description

This study was a double-blind, randomized clinical trial (RCT). Two concentrations of ADSC-CM were utilized: concentrated and non-concentrated ADSC-CM. The scalp was divided vertically in half; one side was injected with 2 ml of ADSC-CM, while the control side received 2 ml of NaCl 0,9%. After the injection, patients applied topical 5% minoxidil twice daily. Clinical improvements were assessed using photographic evaluation and trichoscan every two weeks.

Interventions

COMBINATION_PRODUCTNon-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil

Non-concentrated ADSC-CM is given during week 0, 2, 4, and 6 on the left side of the scalp. Minoxidil is applied twice using a spray, in the morning and at night.

COMBINATION_PRODUCTConcentrated adipose-derived stem cell conditioned media and 5% Minoxidil

Intervention is given during week 0, 2, 4, and 6 on the left side of the scalp. Minoxidil is applied twice using a spray, in the morning and at night.

COMBINATION_PRODUCTPlacebo and 5% Minoxidil

Intervention is given during week 0, 2, 4, and 6 on the right side of the scalp. Minoxidil is applied twice using a spray, in the morning and at night.

Sponsors

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
CollaboratorOTHER_GOV
PT. Kimia Farma (Persero) Tbk
CollaboratorINDUSTRY
Dr. dr. Lili Legiawati, SpKK(K)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
25 Years to 58 Years
Healthy volunteers
Yes

Inclusion criteria

* males aged 25-58 years old * Hamilton-Norwood criteria grades II to VI * cessation of anti-androgens and minoxidil treatment for at least one month

Exclusion criteria

* patients with hair loss other than AGA, such as alopecia areata, chemotherapy-induced alopecia, autoimmune-induced alopecia, and scalp malignancies; * patients receiving 5-alpha reductase inhibitor therapy; * patients who had received growth factor treatment (platelet-rich plasma or microneedling) for at least six months prior to the study; and * history of hypertrophic scars or blood clotting disorders.

Design outcomes

Primary

MeasureTime frameDescription
Hair countWithin 6 weeksSum of hair
Mean thicknessWithin 6 weeksIn centimeters
Total follicular unitsWithin 6 weeksUnit of hair follicles
Vellus rateWithin 6 weeksPercentage of terminal hairs
Hair densityWithin 6 weekscount/cm2
Terminal rateWithin 6 weeksPercentage of terminal hairs

Secondary

MeasureTime frameDescription
7-point scaleWithin 6 weeksIn order to assess patient satisfaction of the research process and treatment outcome

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026