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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-10-31

Brief Summary

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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,

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Detailed Description

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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

Conditions

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Muscular Dystrophy Duchenne Muscular Dystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intralesional and Intravenous

Intralesional/ Intravenous of Autologous Stem cells.

Group Type OTHER

Intralesional/ Intravenous of Autologous Stem cells.

Intervention Type OTHER

Intralesional/ Intravenous of Autologous MNCs per dose

Interventions

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Intralesional/ Intravenous of Autologous Stem cells.

Intralesional/ Intravenous of Autologous MNCs per dose

Intervention Type OTHER

Other Intervention Names

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Intralesional/ Intravenous of Autologous MNCs. Intralesional/ Intravenous of Autologous MNCs

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes