Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03388840|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Biological: Adipose derived stem cells suspention Biological: Platelet rich plasma Other: normal saline||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Effect of Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction Hair Transplantion in Male Androgenic Alopecia: Clinical Trial|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: Adipose derived stem cells suspention
suspension rich in adipose derived stem cells will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia
Biological: Adipose derived stem cells suspention
application of adipose derived stem cells to the engrafted hair in hair transplantation surgery
Active Comparator: Platelet rich plasma
platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia
Biological: Platelet rich plasma
application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery
Placebo Comparator: conventional follicular unit extraction
normal saline will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia
Other: normal saline
application of normal saline to the engrafted hair during hair transplantation
- hair growth [ Time Frame: 12 months ]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.
- hair shaft diameter [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388840
|Contact: Azza M Abdel-Meguid, PHDfirstname.lastname@example.org|
|Contact: Doaa A Abou-Taleb, PHDemail@example.com|
|Assiut university hospitals||Recruiting|
|Contact: A H Ghazally, M.S. 01007224787 firstname.lastname@example.org|
|Principal Investigator:||Alaa H Ghazally, MD||Assiut University|