Combination of SVF and PRP for Androgenetic AlopeciaPhase 2AGANCT02865421
Adipose Tissue Derived Stem Cell Based Hair Restoration Therapy for Androgenetic Alopecia
A Phase 2 study testing stem cells and platelet rich plasma in people with Combination of SVF and PRP for Androgenetic Alopecia, run by King Edward Medical University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Combination of SVF and PRP for Androgenetic Alopecia
- What is being tested?
- stem cells and platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2017to 31 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- stem cells, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cellsDrug
Also called stromal vascular fraction
adipose tissue derived stromal vascular fraction
platelet rich plasmaDrug
platelet rich plasma transplanted in bald area at a distance
| Study group | Role | What they receive |
|---|---|---|
| Stem cells | Experimental | adipose tissue derived stromal vascular fraction was used Receives: Drug: stem cells |
| platelet rich plasma | Experimental | platelet rich plasma isolated after centrifugation from the pt was transplanted Receives: Drug: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start10 Jun 2017
- Primary completion12 Aug 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Combination of SVF and PRP for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmood S Choudhery, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865421
- Sponsor's protocol ID
- King Edward Medical University
- Acronym
- AGA
- Status last verified
- Jan 2018
- First submitted
- 21 Jun 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Derived Stem Cell Based Hair Restoration Therapy for Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT02865421
- Acronym / sponsor ID
- AGA / King Edward Medical University
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem cells | Experimental | Drug: stem cellsadipose tissue derived stromal vascular fraction was used |
| platelet rich plasma | Experimental | Drug: platelet rich plasmaplatelet rich plasma isolated after centrifugation from the pt was transplanted |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- Pregnancy
- Diabetes
- Malignancy
- Global scalp hair thinning including occipital areas
- Patients with scalp inflammation, scalp infection (bacterial, viral, fungal and protozoal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stem cellsAlso: stromal vascular fractionadipose tissue derived stromal vascular fraction | Drug | Stem cells |
| platelet rich plasmaplatelet rich plasma transplanted in bald area at a distance | Drug | platelet rich plasma |
Primary outcome
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.
1 secondary outcome
Trichoscan
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Results publication: PubMed 21601948Reid 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stem cells and platelet rich plasma in people with Combination of SVF and PRP for Androgenetic Alopecia, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pull test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.