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

March 15, 2022 updated by: Dr. dr. Lili Legiawati, SpKK(K)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10430
        • Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair count
Time Frame: Within 6 weeks
Sum of hair
Within 6 weeks
Hair density
Time Frame: Within 6 weeks
count/cm2
Within 6 weeks
Terminal rate
Time Frame: Within 6 weeks
Percentage of terminal hairs
Within 6 weeks
Vellus rate
Time Frame: Within 6 weeks
Percentage of terminal hairs
Within 6 weeks
Mean thickness
Time Frame: Within 6 weeks
In centimeters
Within 6 weeks
Total follicular units
Time Frame: Within 6 weeks
Unit of hair follicles
Within 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-point scale
Time Frame: Within 6 weeks
In order to assess patient satisfaction of the research process and treatment outcome
Within 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. dr. Lili Legiawati, SpKK(K)

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KET-19UN2.F1ETIKPPM00022020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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