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

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ClinicalTrials.gov Identifier: NCT03388840
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
A Ghazally, Assiut University

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Biological: Adipose derived stem cells suspention Biological: Platelet rich plasma Other: normal saline Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Azza M Abdel-Meguid, PHD 01001801039 azzamahfouz@yahoo.com
Contact: Doaa A Abou-Taleb, PHD 01001463937 dodda_aboutaleb@yahoo.com

Locations
Egypt
Assiut university hospitals Recruiting
Assiut, Egypt
Contact: A H Ghazally, M.S.    01007224787    alaaghazally@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Alaa H Ghazally, MD Assiut University

Publications:
Responsible Party: A Ghazally, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03388840     History of Changes
Other Study ID Numbers: ADSCPRPFUE
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by A Ghazally, Assiut University:
platelet rich plasma
adipose derived stem cells
follicular unit extraction
hair transplantation

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical