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

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Adipose derived stem cells suspention
Platelet rich plasma
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring platelet rich plasma, adipose derived stem cells, follicular unit extraction, hair transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adipose derived stem cells suspention

Platelet rich plasma

Arm 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

platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia

Outcomes

Primary Outcome Measures

hair growth
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
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.

Full Information

First Posted
December 23, 2017
Last Updated
September 16, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03388840
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
platelet rich plasma, adipose derived stem cells, follicular unit extraction, hair transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adipose derived stem cells suspention
Arm Type
Experimental
Arm 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
Arm Title
Platelet rich plasma
Arm Type
Active Comparator
Arm Description
platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia
Intervention Type
Biological
Intervention Name(s)
Adipose derived stem cells suspention
Intervention Description
application of adipose derived stem cells to the engrafted hair in hair transplantation surgery
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma
Intervention Description
application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery
Primary Outcome Measure Information:
Title
hair growth
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
hair shaft diameter
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azza M Abdel-Meguid, PHD
Phone
01001801039
Email
azzamahfouz@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa A Abou-Taleb, PHD
Phone
01001463937
Email
dodda_aboutaleb@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa H Ghazally, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A H Ghazally, M.S.
Phone
01007224787
Email
alaaghazally@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28396101
Citation
Adil A, Godwin M. The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis. J Am Acad Dermatol. 2017 Jul;77(1):136-141.e5. doi: 10.1016/j.jaad.2017.02.054. Epub 2017 Apr 7.
Results Reference
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PubMed Identifier
29076290
Citation
Navarro RM, Pino A, Martinez-Andres A, Molina C, Martinez AM, Martinez N, Orive G, Anitua E. The effect of plasma rich in growth factors combined with follicular unit extraction surgery for the treatment of hair loss: A pilot study. J Cosmet Dermatol. 2018 Oct;17(5):862-873. doi: 10.1111/jocd.12446. Epub 2017 Oct 26.
Results Reference
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PubMed Identifier
28483047
Citation
Jimenez-Acosta F, Ponce-Rodriguez I. Follicular Unit Extraction for Hair Transplantation: An Update. Actas Dermosifiliogr. 2017 Jul-Aug;108(6):532-537. doi: 10.1016/j.ad.2017.02.015. Epub 2017 May 5. English, Spanish.
Results Reference
background
PubMed Identifier
24591533
Citation
Qi J, Garza LA. An overview of alopecias. Cold Spring Harb Perspect Med. 2014 Mar 1;4(3):a013615. doi: 10.1101/cshperspect.a013615.
Results Reference
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Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction

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