Brief Title
Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction
Official Title
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
Brief Summary
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
hair growth
Secondary Outcome
hair shaft diameter
Condition
Androgenetic Alopecia
Intervention
Adipose derived stem cells suspention
Study Arms / Comparison Groups
Adipose derived stem cells suspention
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
40
Start Date
January 15, 2018
Completion Date
March 2021
Primary Completion Date
January 2021
Eligibility Criteria
Inclusion Criteria: - male patients with androgenetic alopecia between 18 years and 60 years Exclusion Criteria: 1. Patients with Non-androgenetic causes of hair loss. 2. Female patients with androgenetic alopecia. 3. Patients who received anti-hair loss treatment within the past six months. 4. Patients with history of bleeding disorders or on anticoagulant therapy. 5. Patients with history of chronic liver disease, cancer or connective tissue disorders. 6. Patients with current scalp infection.
Gender
Male
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Alaa H Ghazally, MD, 01001801039, [email protected]
Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT03388840
Organization ID
ADSCPRPFUE
Responsible Party
Principal Investigator
Study Sponsor
Assiut University
Study Sponsor
Alaa H Ghazally, MD, Principal Investigator, Assiut University
Verification Date
February 2018