We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adipose Tissue Derived Stem Cell Based Hair Restoration Therapy for Androgenetic Alopecia (AGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02865421
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Androgenetic alopecia (AGA) is a common form of hair loss in both men and women, characterized by progressive patterned loss of hair from the scalp. The current study has been designed for restoration of hair in AGA by using a combination of stromal vascular fraction (derived from the adipose tissue) and human platelet rich plasma.

Condition or disease Intervention/treatment Phase
Combination of SVF and PRP for Androgenetic Alopecia Drug: stem cells Drug: platelet rich plasma Phase 2

Detailed Description:

Androgenetic alopecia (AGA) is a common form of hair loss in both men and women, characterized by progressive patterned loss of hair from the scalp. The prevalence of AGA increases significantly with age, 30% to 50% men are affected by the age of 30 and 50 years, respectively. 3 Further, women also suffer from different degrees of alopecia, 50% women are affected by the age of 60. AGA becomes a medical problem when the hair loss is subjectively considered as excessive, premature and distressing. Current treatment options for AGA include medications such as finasteride, dutasteride, spironolactone, flutamide, minoxidil etc. However, these medicines are suitable either for men or women only or they can only maintain existing hair but have no effect on hair regeneration. In addition treatment is expensive and requires prolonged usage of drugs, and if treatment is stopped any benefits gained will be lost. Therefore, a better solution is required that can stimulate the hair follicles to promote hair restoration in both sexes with long lasting effects. Recently, stem cell based therapies have revolutionized the field of regenerative medicine by providing treatment options for several diseases and disorders.

The current study has been designed for restoration of hair in AGA by implanting a combination of stromal vascular fraction (derived from the adipose tissue) and human platelet rich plasma.

The growth of human hair is an extremely complex process. Hair growth begins under the skin in structures called hair follicles. In AGA the size of hair follicles decreases due to loss of hair follicle stem or progenitor cells as a result hair follicles become inactive. Due to the inactivation of hair follicles large, pigmented terminal hairs are replaced by barely visible and de-pigmented vellus hairs. External factors can stimulate inactive hair follicles, as a result hair growth cycle can begin. other studies indicate that proteins and growth factors released by stem cells can play an important role in hair growth cycle. Considering these facts, current study has been designed as a possibility in the treatment of AGA by using a combination of autologous SVF and platelet rich plasma. In the current study,SVF derived from adipose tissue will be applied to restore hair growth.

Further, stem cells may also secrete various growth factors which can perform several functions including hair follicle stimulation.

Conventional approaches for hair refurbishment include medication and hair follicle transplantation surgery. However, these strategies are mostly ineffective in patients due to drawbacks including high cost, several side effects, unsatisfactory results, requirement for long lasting use of medicines and their efficacy is limited to either males or females. Therefore, contemporary therapies with promising results are required that should be effective in both sexes and outcomes should be long lasting. Stromal vascular fraction(SVF) based treatment for AGA can open a new avenue for the development of therapies for hair restoration. SVF can have multiple effects on miniaturized hair follicles by homing to the hair follicles and by their paracrine effects. The study will not only help the patients with hair loss but will also promote stem cell based regenerative medicine research in Pakistan by providing promising results.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose Tissue Derived Stem Cell Based Hair Restoration Therapy for Androgenetic Alopecia
Actual Study Start Date : June 10, 2017
Primary Completion Date : August 12, 2017
Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Stem cells
adipose tissue derived stromal vascular fraction was used
Drug: stem cells
adipose tissue derived stromal vascular fraction
Other Name: stromal vascular fraction
Experimental: platelet rich plasma
platelet rich plasma isolated after centrifugation from the pt was transplanted
Drug: platelet rich plasma
platelet rich plasma transplanted in bald area at a distance


Outcome Measures

Primary Outcome Measures :
  1. pull test [ Time Frame: 6 months ]
    Approximately 20-60 hairs were grasped between the thumb, index and middle fingers from the base of the hairs near the scalp and firmly, but not forcefully, tugged away from the scalp.


Secondary Outcome Measures :
  1. Trichoscan [ Time Frame: 6 months ]
    Trichoscan is a method which combines standard epiluminescence microscopy with automatic digital image analysis for the measurement of all important hair parameters in situ.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 15 year or older
  • Both males and females
  • Patients diagnosed as male AGA, type III to VI using Hamilton - Norwood classification, as female pattern hair loss type I-III using Ludwig classification
  • Active hair loss within last 12 months.
  • Patients receiving fitness certificate from fitness committee (Medical Specialist, Plastic Surgeon and Anesthetist)

Exclusion Criteria:

  • Pregnancy
  • Diabetes
  • Malignancy
  • Global scalp hair thinning including occipital areas
  • Patients with scalp inflammation, scalp infection (bacterial, viral, fungal and protozoal)
  • Patients on anticoagulant therapy
  • Patient on chemotherapy during the last five years
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865421


Locations
Pakistan
King Edward Medical University
Lahore, Punjab, Pakistan
Sponsors and Collaborators
King Edward Medical University
More Information

Publications:
Responsible Party: Mahmood S Choudhery, Assistant Professor, King Edward Medical University
ClinicalTrials.gov Identifier: NCT02865421     History of Changes
Other Study ID Numbers: King Edward Medical University
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical