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

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388840
• Other study ID #: ADSCPRPFUE
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2018
• Est. completion date: March 2021

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: Azza M Abdel-Meguid, PHD
• Phone: 01001801039
• Email: azzamahfouz[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Biological:
• Adipose derived stem cells suspention
application of adipose derived stem cells to the engrafted hair in hair transplantation surgery
• Platelet rich plasma
application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. — View Citation

Jiménez-Acosta F, Ponce-Rodríguez 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. — View 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. 2017 Oct 26. doi: 10.1111/jocd.12446. [Epub ahead of print] — View Citation

Qi J, Garza LA. An overview of alopecias. Cold Spring Harb Perspect Med. 2014 Mar 1;4(3). pii: a013615. doi: 10.1101/cshperspect.a013615. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months