Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.
mdp
Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial
1 other identifier
interventional
25
1 country
1
Brief Summary
This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow derived autologous cell(100 million per dose) for the patient with Duchenne Muscular Dystrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 17, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedSeptember 17, 2014
September 1, 2014
2.2 years
February 26, 2013
September 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Significant Improvement in Muscle strength by using Kinetics Muscle testing or by using MMT( manual muscle test }score
6 Months
Secondary Outcomes (1)
-Improvement of daily living scale and baseline in EMG(electromyography)
6 months
Study Arms (1)
STEM CELL
OTHERIntra thecal transplantation of autologous Stem Cell MNCs
Interventions
Intralesional transfer of Autologous Stem cell (MNCs) per dose. 6 doses in 3 months
Eligibility Criteria
You may qualify if:
- Patient with Diagnose of Duchenne Muscular Dystrophy.
- Aged in between 6 to 25 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
You may not qualify if:
- Patient who is not Diagnose of Duchenne Muscular Dystrophy.
- Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+,Tumor Markers+
- History of Life threatening allergic or immune -Mediated Reaction.
- the site of bone marrow aspiration potentially limiting Procedure.
- Alcohol and drug abuse / dependence.
- Patients with History of Hypertension and Hypersensitive.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaitnany Hospital
Pune, Maharashtra, 411009, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANANT E BAGUL, MS ORTHO
CHAITANYA HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- C0- Investigator
Study Record Dates
First Submitted
February 26, 2013
First Posted
April 17, 2013
Study Start
September 1, 2014
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
September 17, 2014
Record last verified: 2014-09