Stem Cell Therapy in Duchenne Muscular Dystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02241434
• Date of registration: 12/09/2014
• Prospective Registration: No
• Primary sponsor: Neurogen Brain and Spine Institute
• Public title: Stem Cell Therapy in Duchenne Muscular Dystrophy
• Scientific title: The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy
• Date of first enrolment: January 2009
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02241434
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

India

Key inclusion & exclusion criteria

Inclusion Criteria:

- age group of 3-25 years

- Duchenne muscular dystrophy diagnosed on the basis of clinical presentation

Exclusion Criteria:

- presence of respiratory distress

- presence of acute infections such as Human Immunodeficient Virus/Hepatitis B
Virus/Hepatitis C Virus

- malignancies

- acute medical conditions such as respiratory infection, fever, hemoglobin less than 8,
bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%

- pregnancy or breastfeeding



Age minimum: 3 Years
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy

Intervention(s)

Biological: Stem Cell

Primary Outcome(s)

Manual Muscle Testing [Time Frame: 1 year]

Secondary Outcome(s)

Brooke and Vignos Scale [Time Frame: 1 year]

Secondary ID(s)

NGBSI-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors