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CompletedNCT02865421AGAUpdated Jan 11, 2018

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

A Phase 2 interventional study of stem cells and platelet rich plasma in Combination of SVF and PRP for Androgenetic Alopecia, sponsored by King Edward Medical University. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-11.

Sponsored by King Edward Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
15 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Combination of SVF and PRP for Androgenetic Alopecia
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 22 is below the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

King Edward Medical University is the lead sponsor of 78 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Stem cells

    adipose tissue derived stromal vascular fraction was used

    Drug: stem cells

  • Experimental
    platelet rich plasma

    platelet rich plasma isolated after centrifugation from the pt was transplanted

    Drug: platelet rich plasma

Interventions

  • Drugstem cells

    adipose tissue derived stromal vascular fraction

    Also known as: stromal vascular fraction

  • Drugplatelet rich plasma

    platelet rich plasma transplanted in bald area at a distance

06

What researchers measure

Primary outcomes

  1. pull test

    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.

    Time frame: 6 months

Secondary outcomes

  1. Trichoscan

    Trichoscan is a method which combines standard epiluminescence microscopy with automatic digital image analysis for the measurement of all important hair parameters in situ.

    Time frame: 6 months

07

Study locations

1 site
  • King Edward Medical University
    Lahore, Punjab, Pakistan
08

References and documents

Publications

  • Reid EE, Haley AC, Borovicka JH, Rademaker A, West DP, Colavincenzo M, Wickless H. Clinical severity does not reliably predict quality of life in women with alopecia areata, telogen effluvium, or androgenic alopecia. J Am Acad Dermatol. 2012 Mar;66(3):e97-102. doi: 10.1016/j.jaad.2010.11.042. Epub 2011 May 24. PubMed 21601948 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02865421
Lead sponsor
King Edward Medical University
Responsible party
Mahmood S Choudhery (Assistant Professor, King Edward Medical University) — Principal investigator
First posted
Aug 12, 2016
Start date
Jun 10, 2017
Primary completion
Aug 12, 2017
Completion
Dec 31, 2017
Last update
Jan 11, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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