A Phase 1/2 interventional study of Mesenchymal Stem Cells and 0.9 % saline in Androgenetic Alopecia and Androgenetic Alopecia (AGA), sponsored by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan. Enrolling by invitation at 2 sites in Pakistan. Open to male participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan · Phase 1/2, Interventional, and Treatment
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:
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.
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.
ii. To determine and compare the investigators assessment and patient satisfaction in both groups.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's planned enrollment of 70 is above the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →National Institute of Blood and Marrow Transplant (NIBMT), Pakistan is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
MSC therapy group
Biological: Mesenchymal Stem Cells
Placebo (0.9% saline)
Other: 0.9 % saline
allogeneic bone marrow-derived mesenchymal stem cells therapy
0.9% Saline as placebo
Changes from baseline in hair count
Primary efficacy variables will be the changes from baseline in hair count
Time frame: 12 weeks post intervention
Change in baseline hair diameter
Change in baseline diameter measured through trichoscopic analysis.
Time frame: 12 weeks post-intervention
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
Time frame: 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). 5. Extremely Dissatisfied 4. Satisfied 3. Neutral 2. Dissatisfied 1. Extremely Dissatisfied
Time frame: 12 weeks post-treatment
Plan to share: No
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National Institute of Blood and Marrow Transplant (NIBMT), Pakistan