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

NCT ID: NCT03388840

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Adipose derived stem cells suspention

Intervention Type BIOLOGICAL

application of adipose derived stem cells to the engrafted hair in hair transplantation surgery

Platelet rich plasma

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

Group Type ACTIVE_COMPARATOR

Platelet rich plasma

Intervention Type BIOLOGICAL

application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery

Interventions

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Adipose derived stem cells suspention

application of adipose derived stem cells to the engrafted hair in hair transplantation surgery

Intervention Type BIOLOGICAL

Platelet rich plasma

application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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A Ghazally

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa H Ghazally, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut university hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Azza M Abdel-Meguid, PHD

Role: CONTACT

01001801039

Doaa A Abou-Taleb, PHD

Role: CONTACT

01001463937

Facility Contacts

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A H Ghazally, M.S.

Role: primary

01007224787

References

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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.

Reference Type BACKGROUND
PMID: 28396101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29076290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28483047 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24591533 (View on PubMed)

Other Identifiers

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ADSCPRPFUE

Identifier Type: -

Identifier Source: org_study_id

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