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

NCT05296863 | Completed Phase 3

• 1 other identifier: KET-19UN2.F1ETIKPPM00022020
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia, Androgenetic; Hair Loss/Baldness

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Hair count

  Sum of hair

  Within 6 weeks

• Hair density

  count/cm2

  Within 6 weeks

• Terminal rate

  Percentage of terminal hairs

  Within 6 weeks

• Vellus rate

  Percentage of terminal hairs

  Within 6 weeks

• Mean thickness

  In centimeters

  Within 6 weeks

• Total follicular units

  Unit of hair follicles

  Within 6 weeks

Secondary Outcomes (1)

• 7-point scale

  Within 6 weeks

Study Arms (2)

Non-concentrated ADSC-CM

EXPERIMENTAL

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; Combination Product: Placebo and 5% Minoxidil

Concentrated ADSC-CM

EXPERIMENTAL

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; Combination Product: Placebo and 5% Minoxidil

Interventions

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

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.

Non-concentrated ADSC-CM

Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil COMBINATION_PRODUCT

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.

Concentrated ADSC-CM

Placebo and 5% Minoxidil COMBINATION_PRODUCT

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.

Concentrated ADSC-CM; Non-concentrated ADSC-CM

Eligibility Criteria

• Age: 25 Years - 58 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. dr. Lili Legiawati, SpKK(K): lead
• Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia: collaborator
• PT. Kimia Farma (Persero) Tbk: collaborator

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (31)

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  PMID: 37605227 DERIVED

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 25, 2022
• Study Start: October 11, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

ID (1)