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Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy

Study Safety and Efficacy of of AUTOLOGOUS Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) for the Patient With Duchenne Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01834040
Acronym
BMMNC
Enrollment
30
Registered
2013-04-17
Start date
2014-09-30
Completion date
2016-10-31
Last updated
2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy, Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy, Muscular Dystrophy, Myopathy

Brief summary

This Study is single arm, single center trial to check the safety and efficacy of BMMNC (100 million per dose) for the patient with Duchenne Muscular Dystrophy,

Detailed description

Muscular dystrophies, or MD, are a group of inherited conditions, which means they are passed down through families. They may occur in childhood or adulthood. There are many different types of muscular dystrophy. They include: Duchenne muscular dystrophy is a form of muscular dystrophy that worsens quickly. Other muscular dystrophy (including Becker's muscular dystrophy) get worse much more slowly. Duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition. Symptoms usually appear before age 6 and may appear as early as infancy. They may include: Fatigue Learning difficulties (the IQ (intelligence quotient )can be below 75) Intellectual disability (possible, but does not get worse over time) Muscle weakness Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body Difficulty with motor skills (running, hopping, jumping) Frequent falls Trouble getting up from a lying position or climbing stairs Weakness quickly gets worse Progressive difficulty walking Ability to walk may be lost by age 12, and the child will have to use a wheelchair Breathing difficulties and heart disease usually start by age 20

Interventions

OTHERIntralesional/ Intravenous of Autologous Stem cells.

Intralesional/ Intravenous of Autologous MNCs per dose

Sponsors

Chaitanya Hospital, Pune
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* Patient with Diagnose of Duchenne Muscular Dystrophy. * Aged in between 4 to 20 Years. * Willingness to undergo Bone Marrow derived Autologous cell Therapy. * Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study. * Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion criteria

* Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+, Tumor Markers+ * Patients with History of Hypertension and Hypersensitive. * Patient who is not Diagnose of Duchenne Muscular Dystrophy. * Alcohol and drug abuse / dependence.

Design outcomes

Primary

MeasureTime frame
Improvement of daily living scale.6 MONTH

Secondary

MeasureTime frame
Improvement of Muscular dystrophy specific functional Rating scale6 Months

Countries

India

Contacts

Primary ContactSachin S Jamadar, Dortho
sac2751982@gmail.com+918888788880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026