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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alopecia, Androgenetic, Hair Loss/Baldness

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-concentrated ADSC-CM<br>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<br>* 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.<br>Combination Product: Placebo and 5% Minoxidil<br>* 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.<br>|
| Experimental: Concentrated ADSC-CM<br>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<br>* 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.<br>Combination Product: Placebo and 5% Minoxidil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell therapy, Adipose derived stem cell conditioned media, Hair regeneration