Clinical trial NCT03388840: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Androgenetic Alopecia
Keywords: platelet rich plasma
adipose derived stem cells
follicular unit extraction
hair transplantation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: hair growth
timeFrame: 12 months
Secondary outcomes:
measure: hair shaft diameter
timeFrame: 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: Assiut University
name: Alaa H Ghazally, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.