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

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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