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

Sponsor

Dr. dr. Lili Legiawati, SpKK(K) (Other)

Overall Status

Completed

CT.gov ID

NCT05296863

Collaborator

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia (Other), PT. Kimia Farma (Persero) Tbk (Industry)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

21.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia, Androgenetic Hair Loss/Baldness	Combination Product: Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil Combination Product: Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil Combination Product: Placebo and 5% Minoxidil	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 11, 2021

Actual Primary Completion Date :

Dec 3, 2021

Actual Study Completion Date :

Dec 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-concentrated ADSC-CM 2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily	Combination Product: Non-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 Product: Placebo 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.
Experimental: Concentrated ADSC-CM 2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily	Combination Product: Concentrated 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 Product: Placebo 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.

Arm

Intervention/Treatment

Experimental: Non-concentrated ADSC-CM

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

Combination Product: Non-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 Product: Placebo 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.

Experimental: Concentrated ADSC-CM

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

Combination Product: Concentrated 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 Product: Placebo 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.

Outcome Measures

Primary Outcome Measures

Hair count [Within 6 weeks]
Sum of hair
Hair density [Within 6 weeks]
count/cm2
Terminal rate [Within 6 weeks]
Percentage of terminal hairs
Vellus rate [Within 6 weeks]
Percentage of terminal hairs
Mean thickness [Within 6 weeks]
In centimeters
Total follicular units [Within 6 weeks]
Unit of hair follicles

Secondary Outcome Measures

7-point scale [Within 6 weeks]
In order to assess patient satisfaction of the research process and treatment outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 58 Years

Sexes Eligible for Study:

Male

Accepts 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.