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

Primary Purpose

Combination of SVF and PRP for Androgenetic Alopecia

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
stem cells
platelet rich plasma
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Combination of SVF and PRP for Androgenetic Alopecia

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • King Edward Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stem cells

platelet rich plasma

Arm Description

adipose tissue derived stromal vascular fraction was used

platelet rich plasma isolated after centrifugation from the pt was transplanted

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 21, 2016
Last Updated
January 10, 2018
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02865421
Brief Title
Adipose Tissue Derived Stem Cell Based Hair Restoration Therapy for Androgenetic Alopecia
Acronym
AGA
Official Title
Adipose Tissue Derived Stem Cell Based Hair Restoration Therapy for Androgenetic Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
August 12, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Combination of SVF and PRP for Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cells
Arm Type
Experimental
Arm Description
adipose tissue derived stromal vascular fraction was used
Arm Title
platelet rich plasma
Arm Type
Experimental
Arm Description
platelet rich plasma isolated after centrifugation from the pt was transplanted
Intervention Type
Drug
Intervention Name(s)
stem cells
Other Intervention Name(s)
stromal vascular fraction
Intervention Description
adipose tissue derived stromal vascular fraction
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma
Intervention Description
platelet rich plasma transplanted in bald area at a distance
Primary Outcome Measure Information:
Title
pull test
Description
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 Outcome Measure Information:
Title
Trichoscan
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
King Edward Medical University
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21601948
Citation
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.
Results Reference
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Adipose Tissue Derived Stem Cell Based Hair Restoration Therapy for Androgenetic Alopecia

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