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

Dr. dr. Lili Legiawati, SpKK(K)

Status and phase: Completed; Phase 3

Conditions: Hair Loss/Baldness; Alopecia, Androgenetic

Treatments: Combination Product: Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil; Combination Product: Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil; Combination Product: Placebo and 5% Minoxidil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05296863

KET-19UN2.F1ETIKPPM00022020

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: Male

Ages: 25 to 58 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups

Non-concentrated ADSC-CM

Experimental group

Description:

2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily

Treatment:

Combination Product: Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil

Combination Product: Placebo and 5% Minoxidil

Concentrated ADSC-CM

Experimental group

Description:

2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily

Treatment:

Combination Product: Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil

Combination Product: Placebo and 5% Minoxidil