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Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy. (mdp)

Primary Purpose

Muscular Dystrophy, Duchenne Muscular Dystrophy,

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Stem Cell
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophy focused on measuring muscular Dystrophy stem cell

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Chaitnany HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STEM CELL

Arm Description

Intra thecal transplantation of autologous Stem Cell MNCs

Outcomes

Primary Outcome Measures

Significant Improvement in Muscle strength by using Kinetics Muscle testing or by using MMT( manual muscle test }score

Secondary Outcome Measures

-Improvement of daily living scale and baseline in EMG(electromyography)

Full Information

First Posted
February 26, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01834066
Brief Title
Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.
Acronym
mdp
Official Title
Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Muscular dystrophy is a group of inherited disorders that involve muscle weakness and loss of muscle tissue, which get worse over time. 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. slowly progress diseases.it causes Muscle weaknesses, Difficulty with motor skills ,Progressive difficulty walking.Breathing difficulties and heart disease,Frequent falls,weak limbs,lose motor Function.Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body.Trouble getting up from a lying position or climbing stairs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophy, Duchenne Muscular Dystrophy,
Keywords
muscular Dystrophy stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEM CELL
Arm Type
Other
Arm Description
Intra thecal transplantation of autologous Stem Cell MNCs
Intervention Type
Biological
Intervention Name(s)
Stem Cell
Other Intervention Name(s)
Intravenous transfer of Autologous Stem Cell ( MNCs )
Intervention Description
Intralesional transfer of Autologous Stem cell (MNCs) per dose. 6 doses in 3 months
Primary Outcome Measure Information:
Title
Significant Improvement in Muscle strength by using Kinetics Muscle testing or by using MMT( manual muscle test }score
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
-Improvement of daily living scale and baseline in EMG(electromyography)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P Jamadar, D.Ortho
Phone
+918888788880
Email
sac2751982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, MS ORTHO
Organizational Affiliation
CHAITANYA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitnany Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin P Jamadar, D ORTHO
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, MS ORTHO

12. IPD Sharing Statement

Learn more about this trial

Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.

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