The Effectiveness of Allogenic Mesenchymal Stem Cells Therapy on Hair Regrowth in Androgenetic Alopecia.

NCT06764329 | Enrolling By Invitation Phase 1

• 1 other identifier: AFBMTC-2024-MSC in Alopecia
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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. 1.Compare the average hair regenerative effect of mesenchymal stem cells versus Placebo, in treatment of androgenetic alopecia.
2. 2.To determine and compare the investigators assessment and patient satisfaction in both groups.

Conditions

Androgenetic Alopecia; Androgenetic Alopecia (AGA)

Keywords

androgenetic alopecia; mesenchymal stem cell; placebo-controlled trial

Outcome Measures

Primary Outcomes (2)

• Changes from baseline in hair count

  Primary efficacy variables will be the changes from baseline in hair count

  12 weeks post intervention

• Change in baseline hair diameter

  Change in baseline diameter measured through trichoscopic analysis.

  12 weeks post-intervention

Secondary Outcomes (2)

• Investigators assessment through photographs of patients' scalp

  12 weeks post-intervention

• Subjective satisfaction of the patient

  12 weeks post-treatment

Study Arms (2)

Treatment

EXPERIMENTAL

MSC therapy group

Biological: Mesenchymal Stem Cells

Placebo group

PLACEBO COMPARATOR

Placebo (0.9% saline)

Other: 0.9 % saline

Interventions

Mesenchymal Stem Cells BIOLOGICAL

allogeneic bone marrow-derived mesenchymal stem cells therapy

Treatment

0.9 % saline OTHER

0.9% Saline as placebo

Placebo group

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Blood and Marrow Transplant (NIBMT), Pakistan: lead
• Pak Emirates Military Hospital: collaborator

Study Sites (2)

Department of dermatology, Pak-Emirates Military Hospital

Rawalpindi, 46000, Pakistan

Location

National Institute of Blood and Marrow Transplant (NIBMT)

Rawalpindi, 46000, Pakistan

Location

MeSH Terms

Conditions

Alopecia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Double-Blind, Randomized, Placebo-Controlled Trial

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 8, 2025
• Study Start: December 25, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)