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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03388840

Collaborator

(none)

Enrollment

Location

Arms

37.5

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 15, 2018

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adipose derived stem cells suspention 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 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

Arm

Intervention/Treatment

Experimental: Adipose derived stem cells suspention

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

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

Outcome Measures

Primary Outcome Measures

hair growth [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

hair shaft diameter [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.