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

Alopecia, Androgenetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296863
• Other study ID #: KET-19UN2.F1ETIKPPM00022020
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2021
• Est. completion date: December 3, 2021

Study information

• Verified date: March 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 58 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia, Androgenetic
• Hair Loss/Baldness

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (3)

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

Country where clinical trial is conducted

Indonesia, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair count	Sum of hair	Within 6 weeks
Primary	Hair density	count/cm2	Within 6 weeks
Primary	Terminal rate	Percentage of terminal hairs	Within 6 weeks
Primary	Vellus rate	Percentage of terminal hairs	Within 6 weeks
Primary	Mean thickness	In centimeters	Within 6 weeks
Primary	Total follicular units	Unit of hair follicles	Within 6 weeks
Secondary	7-point scale	In order to assess patient satisfaction of the research process and treatment outcome	Within 6 weeks