Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction

Study Overview
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Brief Summary
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Androgenetic alopecia is the most common type of alopecia in both men and women. About 80 % of Caucasian men and 40-50 % of Caucasian women are affected by androgenetic alopecia. The psychological impact of hair loss due to Androgenetic alopecia can be profound.

Detailed Description
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Currently, two medications are Food and Drug Administration approved in the treatment of Androgenetic alopecia which are minoxidil, and finasteride. Both medications must be taken indefinitely for benefits to persist. Hair transplantation is the only current successful permanent option. Nowadays, the majority of surgeons use 2 techniques, the classic strip technique, and the follicular unit extraction technique. Advantages of follicular unit extraction over the strip technique are the lesser incidence of donor zone post-procedural discomfort and the barely visible scarring. Platelet rich plasma is an autologous concentration of platelets in small volume of plasma and is an exciting therapeutic option for hair growth. Combining platelet rich plasma with follicular unit extraction surgery for the treatment of Androgenetic alopecia demonstrated that PRP is able to minimize the postsurgical follicle loss and potentiate the performance of grafted hairs. Adipose derived stem cells are an effective mesenchymal stem cell population with enormous potential in different fields of regenerative medicine. Adipose stem cells are needed to induce the proliferation of bulge stem cells of hair follicle. Furthermore, they can help in wound healing and vascular neogenesis. Zanzottera et al. 2014 investigated the effect of adipose derived stem cells on wound healing and engraftment of the transplanted hair applied during hair restoration surgery for three patients with androgenetic alopecia. Despite their promising results, further clinical trials including larger number of patients are still needed to confirm their preliminary findings.

Official Title
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the Effect of Adipose Derived Stem Cells Combined With Platelet Rich Plasma Versus Platelet Rich Plasma Alone on Follicular Unit Extraction Hair Transplantion in Male Androgenic Alopecia: Clinical Trial

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Biological: Adipose derived stem cells suspention
* Biological: Platelet rich plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male patients with androgenetic alopecia between 18 years and 60 years Exclusion Criteria: Patients with Non-androgenetic causes of hair loss. Female patients with androgenetic alopecia. Patients who received anti-hair loss treatment within the past six months. Patients with history of bleeding disorders or on anticoagulant therapy. Patients with history of chronic liver disease, cancer or connective tissue disorders. Patients with current scalp infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose derived stem cells suspention<br>suspension rich in adipose derived stem cells plus platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia | Biological: Adipose derived stem cells suspention<br>* application of adipose derived stem cells to the engrafted hair in hair transplantation surgery<br>|
| Active Comparator: Platelet rich plasma<br>platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia | Biological: Platelet rich plasma<br>* application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hair growth | Evaluate the effect of adipose derived stem cells intradermally injected in the recipient site during follicular unit extraction for the treatment of androgenetic alopecia on transplanted hair growth in terms of hair density (number of hairs / cm2) in the transplanted region using folliscope. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hair shaft diameter | Evaluate the effect of adipose derived stem cells intradermally injected in the recipient site during follicular unit extraction for the treatment of androgenetic alopecia on transplanted hair shaft diameter in mm using folliscope. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma, adipose derived stem cells, follicular unit extraction, hair transplantation