Back to resultsAdipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia
Primary Purpose
Alopecia, Androgenetic, Hair Loss/Baldness
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Placebo and 5% Minoxidil
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia, Androgenetic focused on measuring Stem cell therapy, Adipose derived stem cell conditioned media, Hair regeneration
Eligibility Criteria
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.
Sites / Locations
- Universitas Indonesia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non-concentrated ADSC-CM
Concentrated ADSC-CM
Arm Description
2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
Outcomes
Primary Outcome Measures
Hair count
Sum of hair
Hair density
count/cm2
Terminal rate
Percentage of terminal hairs
Vellus rate
Percentage of terminal hairs
Mean thickness
In centimeters
Total follicular units
Unit of hair follicles
Secondary Outcome Measures
7-point scale
In order to assess patient satisfaction of the research process and treatment outcome
Full Information
NCT ID
NCT05296863
First Posted
February 18, 2022
Last Updated
March 15, 2022
Sponsor
Dr. dr. Lili Legiawati, SpKK(K)
Collaborators
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia, PT. Kimia Farma (Persero) Tbk
1. Study Identification
Unique Protocol Identification Number
NCT05296863
Brief Title
Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. dr. Lili Legiawati, SpKK(K)
Collaborators
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia, PT. Kimia Farma (Persero) Tbk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Androgenetic, Hair Loss/Baldness
Keywords
Stem cell therapy, Adipose derived stem cell conditioned media, Hair regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-concentrated ADSC-CM
Arm Type
Experimental
Arm Description
2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
Arm Title
Concentrated ADSC-CM
Arm Type
Experimental
Arm Description
2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
Intervention Type
Combination Product
Intervention Name(s)
Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo and 5% Minoxidil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hair count
Description
Sum of hair
Time Frame
Within 6 weeks
Title
Hair density
Description
count/cm2
Time Frame
Within 6 weeks
Title
Terminal rate
Description
Percentage of terminal hairs
Time Frame
Within 6 weeks
Title
Vellus rate
Description
Percentage of terminal hairs
Time Frame
Within 6 weeks
Title
Mean thickness
Description
In centimeters
Time Frame
Within 6 weeks
Title
Total follicular units
Description
Unit of hair follicles
Time Frame
Within 6 weeks
Secondary Outcome Measure Information:
Title
7-point scale
Description
In order to assess patient satisfaction of the research process and treatment outcome
Time Frame
Within 6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universitas Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
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Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia
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