Androgenetic AlopeciaPhase 1/2NCT06764329
The Effectiveness of Allogenic Mesenchymal Stem Cells Therapy on Hair Regrowth in Androgenetic Alopecia.
A Phase 1/2 study testing Mesenchymal Stem Cells and 0.9 % saline in people with Androgenetic Alopecia and Androgenetic Alopecia (AGA), run by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan at 2 sites in Pakistan.
Trial summary
The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat adrogenic alopecia or male-pattern baldness, when compared to normal saline (given to placebo group). It will also assess the differences in patient satisfaction. The main focus will be to: 1. Read more about this study
- Who is it for?
- Ages 20 to 59 years, men only
- Conditions the study is for
- Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- What is being tested?
- Mesenchymal Stem Cells and 0.9 % saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Dec 2024to 30 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 20 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients with AGA between age 25 to 59 years of age
- Clinical presentation consistent with Hamilton Norwood criteria grade ll to Vl
- Not currently receiving antiandrogens or minoxidil therapy.
Who cannot join
- Patients with hair loss other than AGA
- Patients receiving 5-alpha reductase inhibitor or minoxidil therapy
- Patients who received PRP for at least 6 months prior to enrollment
- History of hypertrophic scars or bleeding disorders
- History of treatment with hyper or hypothyroidism
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Department of dermatology, Pak-Emirates Military Hospital
Rawalpindi, 46000
National Institute of Blood and Marrow Transplant (NIBMT)
Rawalpindi, 46000
About this study
Official title: The Effectiveness of Allogenic Mesenchymal Stem Cells Therapy on Hair Regrowth in Androgenetic Alopecia: a Randomized, Double-Blind, Placebo Control Trial
The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat adrogenic alopecia or male-pattern baldness, when compared to normal saline (given to placebo group). It will also assess the differences in patient satisfaction. The main focus will be to:
- Compare the average hair regenerative effect of mesenchymal stem cells versus Placebo, in treatment of androgenetic alopecia.
- To determine and compare the investigators assessment and patient satisfaction in both groups.
Patients in treatment group will receive single session of MSC therapy injected in the scalp and placebo group will receive 0.9% saline solution. The participants will be followed for 12 weeks. The hair density and thickness will be mesured along with clinicians assessment and participant's satisfaction level.
Read the detailed description
- Introduction: Androgenetic Alopecia (AGA) is a common form of hair loss affecting both men and women, characterized by the miniaturization of hair follicles due to the influence of a variety of factors including androgens and genetics. AGA affects a sizeable portion of the population worldwide, affecting males and females both.1 While many accept it as a normal physiological process of ageing, for others it causes remarkable concern and worry, especially pertaining to personal appearance and self-confidence. So much so leading to body image issues and even psychological disorders1,2,3. Hence it becomes empirical to treat this condition with aim to achieve patient satisfaction. Current treatment options, such as minoxidil and finasteride, have limitations in efficacy and number of adverse effects which limit their use.1 Mesenchymal derived stem cells (MSCs) have emerged as a potential therapeutic option due to their regenerative and immunomodulatory properties.1 Cell-based therapy has seen a significant rise as an alternative for treating medical disorders in recent years. Specifically, stem cell therapy has been applied to address various dermatological conditions, including alopecia. Stem cells (SCs) are known to play a crucial role in initiating the hair growth cycle and remodeling.1 Emerging evidence suggests that stem cells may be responsible for releasing cytokines, chemokines, and specific growth factors like bFGF, VEGF, IGF-1, HGF, and TGF-β1. These molecules initiate cell repair processes through angiogenesis, immunomodulation, cell differentiation, and proliferation. In the scalp, they exert a paracrine effect on neighboring cells and tissues, promoting hair follicle growth, adjusting hair growth patterns, regulating follicle size via angiogenesis, and supporting the retention of the anagen phase.2,3 A RCT comparing Adipose derived Stem Cell Constituent Extract (ADSC-CE) with Placebo (Distilled water), carried out at Busan National University Yangsan Hospital, Korea showed significant statistical improvement in mean hair count and mean hair diameter in Intervention Group (IG) versus Control Group (CG) 16 weeks post treatment. Change from baseline in Hair Diameter was 0.008 ± 0.007 in IG versus 0.004 ± 0.004 in CG with p value of .023. Change from baseline in Hair counts was 3.89 ± 3.01 in IG versus 1.44 ± 1.97 in CG with p value of .025. In investigator assessment using photographs, intervention failed to show a statistically significant improvement in both groups. In the participants self-assessments, no significant intergroup differences were observed.3 Based on above evidence, there is a vast avenue of research in potential role of MSCs therapy in AGA, as an emerging approach.1,2,3 This study has the potential to pave the way for further advancements in regenerative medicine. This study aims to evaluate the efficacy and safety of MSCs in the treatment of AGA through a double-blind randomized controlled trial (RCT). As current treatments offer limited success, this study is directed to explore potential for a novel, minimally invasive alternative with long term effectiveness and improved outcomes in hair loss management, especially in our population, addressing an unmet clinical need.
- OBJECTIVE i. To compare the mean hair regenerative effect of Mesenchymal derived stem cells (MSCs) versus Placebo, in treatment of androgenetic alopecia (AGA). ii. To determine and compare the investigators assessment and patient satisfaction in both groups.
- Conditions
- Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- Being tested
- Mesenchymal Stem Cells, 0.9 % saline
- Keywords
- androgenetic alopecia, mesenchymal stem cell, placebo-controlled trial
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellsBiological
allogeneic bone marrow-derived mesenchymal stem cells therapy
0.9 % salineOther
0.9% Saline as placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | MSC therapy group Receives: Biological: Mesenchymal Stem Cells |
| Placebo group | Placebo comparator | Placebo (0.9% saline) Receives: Other: 0.9 % saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in hair count
Primary efficacy variables will be the changes from baseline in hair count
Measured: 12 weeks post intervention
Change in baseline hair diameter
Change in baseline diameter measured through trichoscopic analysis.
Measured: 12 weeks post-intervention
Secondary outcomes (2)
Investigators assessment through photographs of patients' scalp
investigators assessment through photographs of patients' scalp pre- and post-intervention. An investigator, blinded to the intervention, will rate the changes in scalp appearance relative to the baseline using a standardized 7-point rating scale with the following scores:
- 3 Greatly decreased
- 2 Moderately decreased
- 1 Slightly decreased 0 Unchanged
- 1 Slightly increased
- 2 Moderately increased
- 3 Greatly increased
Measured: 12 weeks post-intervention
Subjective satisfaction of the patient
Likert scale: subjective satisfaction of the patient, assessed through standardized questions regarding reduction in hair fall and new hair growth.
Changes from baseline in terms of reduction in hairfall and new hair growth will be evaluated by the participants on a 5 point Likert Scale, post treatment (week 12).
- Extremely Dissatisfied 4. Satisfied 3. Neutral 2. Dissatisfied
- Extremely Dissatisfied
Measured: 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start25 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind, Randomized, Placebo-Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
- Sponsor type
- Other government
- Collaborators
- Pak Emirates Military Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764329
- Sponsor's protocol ID
- AFBMTC-2024-MSC in Alopecia
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Allogenic Mesenchymal Stem Cells Therapy on Hair Regrowth in Androgenetic Alopecia: a Randomized, Double-Blind, Placebo Control Trial
- ClinicalTrials.gov ID
- NCT06764329
- Acronym / sponsor ID
- AFBMTC-2024-MSC in Alopecia
- Conditions
- Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- Keywords
- androgenetic alopecia, mesenchymal stem cell, placebo-controlled trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), PakistanOther government
- Collaborators
- Pak Emirates Military Hospital
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 8 Jan 2025 (actual)
- 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.
The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat adrogenic alopecia or male-pattern baldness, when compared to normal saline (given to placebo group). It will also assess the differences in patient satisfaction. The main focus will be to:
- Compare the average hair regenerative effect of mesenchymal stem cells versus Placebo, in treatment of androgenetic alopecia.
- To determine and compare the investigators assessment and patient satisfaction in both groups.
Patients in treatment group will receive single session of MSC therapy injected in the scalp and placebo group will receive 0.9% saline solution. The participants will be followed for 12 weeks. The hair density and thickness will be mesured along with clinicians assessment and participant's satisfaction level.
Detailed description
- Introduction: Androgenetic Alopecia (AGA) is a common form of hair loss affecting both men and women, characterized by the miniaturization of hair follicles due to the influence of a variety of factors including androgens and genetics. AGA affects a sizeable portion of the population worldwide, affecting males and females both.1 While many accept it as a normal physiological process of ageing, for others it causes remarkable concern and worry, especially pertaining to personal appearance and self-confidence. So much so leading to body image issues and even psychological disorders1,2,3. Hence it becomes empirical to treat this condition with aim to achieve patient satisfaction. Current treatment options, such as minoxidil and finasteride, have limitations in efficacy and number of adverse effects which limit their use.1 Mesenchymal derived stem cells (MSCs) have emerged as a potential therapeutic option due to their regenerative and immunomodulatory properties.1 Cell-based therapy has seen a significant rise as an alternative for treating medical disorders in recent years. Specifically, stem cell therapy has been applied to address various dermatological conditions, including alopecia. Stem cells (SCs) are known to play a crucial role in initiating the hair growth cycle and remodeling.1 Emerging evidence suggests that stem cells may be responsible for releasing cytokines, chemokines, and specific growth factors like bFGF, VEGF, IGF-1, HGF, and TGF-β1. These molecules initiate cell repair processes through angiogenesis, immunomodulation, cell differentiation, and proliferation. In the scalp, they exert a paracrine effect on neighboring cells and tissues, promoting hair follicle growth, adjusting hair growth patterns, regulating follicle size via angiogenesis, and supporting the retention of the anagen phase.2,3 A RCT comparing Adipose derived Stem Cell Constituent Extract (ADSC-CE) with Placebo (Distilled water), carried out at Busan National University Yangsan Hospital, Korea showed significant statistical improvement in mean hair count and mean hair diameter in Intervention Group (IG) versus Control Group (CG) 16 weeks post treatment. Change from baseline in Hair Diameter was 0.008 ± 0.007 in IG versus 0.004 ± 0.004 in CG with p value of .023. Change from baseline in Hair counts was 3.89 ± 3.01 in IG versus 1.44 ± 1.97 in CG with p value of .025. In investigator assessment using photographs, intervention failed to show a statistically significant improvement in both groups. In the participants self-assessments, no significant intergroup differences were observed.3 Based on above evidence, there is a vast avenue of research in potential role of MSCs therapy in AGA, as an emerging approach.1,2,3 This study has the potential to pave the way for further advancements in regenerative medicine. This study aims to evaluate the efficacy and safety of MSCs in the treatment of AGA through a double-blind randomized controlled trial (RCT). As current treatments offer limited success, this study is directed to explore potential for a novel, minimally invasive alternative with long term effectiveness and improved outcomes in hair loss management, especially in our population, addressing an unmet clinical need.
- OBJECTIVE i. To compare the mean hair regenerative effect of Mesenchymal derived stem cells (MSCs) versus Placebo, in treatment of androgenetic alopecia (AGA). ii. To determine and compare the investigators assessment and patient satisfaction in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-Blind, Randomized, Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Mesenchymal Stem CellsMSC therapy group |
| Placebo group | Placebo comparator | Other: 0.9 % salinePlacebo (0.9% saline) |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male patients with AGA between age 25 to 59 years of age
- Clinical presentation consistent with Hamilton Norwood criteria grade ll to Vl
- Not currently receiving antiandrogens or minoxidil therapy.
Key exclusion criteria (5 listed)
- Patients with hair loss other than AGA
- Patients receiving 5-alpha reductase inhibitor or minoxidil therapy
- Patients who received PRP for at least 6 months prior to enrollment
- History of hypertrophic scars or bleeding disorders
- History of treatment with hyper or hypothyroidism
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 |
|---|---|---|
| Mesenchymal Stem Cellsallogeneic bone marrow-derived mesenchymal stem cells therapy | Biological | Treatment |
| 0.9 % saline0.9% Saline as placebo | Other | Placebo group |
Primary outcome
Changes from baseline in hair count
Time frame: 12 weeks post intervention
Primary efficacy variables will be the changes from baseline in hair count
Change in baseline hair diameter
Time frame: 12 weeks post-intervention
Change in baseline diameter measured through trichoscopic analysis.
2 secondary outcomes
Investigators assessment through photographs of patients' scalp
Time frame: 12 weeks post-intervention
Subjective satisfaction of the patient
Time frame: 12 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stem Cells and 0.9 % saline in people with Androgenetic Alopecia and Androgenetic Alopecia (AGA), run by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan at 2 sites 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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
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?
Changes from baseline in hair count (time frame: 12 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2025.