Trial record 15 of 53 for:    Open Studies | "Muscular Dystrophy, Duchenne"

Study Safety and Efficacy of Umbilical Cord Derived Cell for the Patient With Duchenne Muscular Dystrophy (HUCMSC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Chaitanya Hospital, Pune
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune Identifier:
First received: February 26, 2013
Last updated: April 15, 2013
Last verified: April 2013

This Study is single arm, single centre trial to check the safety and efficacy of umbilical cord derived cell(100 million per dose) for the patient with Duchenne Muscular Dystrophy, since March 2011.

Condition Intervention Phase
Muscular Dystrophy
Duchenne Muscular Dystrophy
Other: Intralesional/ Intravenous of Autologous Stem cells.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Safety and Efficacy of Umbilical Cord Derived Cell for the Patient With Duchenne Muscular Dystrophy.

Resource links provided by NLM:

Further study details as provided by Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • Improvement of daily living scale. [ Time Frame: 6 MONTH ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of Muscular dystrophy specific functional Rating scale [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
intralesional and Intravenous
Intralesional/ Intravenous of Autologous Stem cells.
Other: Intralesional/ Intravenous of Autologous Stem cells.
Intralesional/ Intravenous of Autologous MNCs per dose
Other Names:
  • Intralesional/ Intravenous of Autologous MNCs.
  • Intralesional/ Intravenous of Autologous MNCs

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 dystrophies (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:


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


Ages Eligible for Study:   4 Years to 20 Years
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01834040

Contact: Sachin S Jamadar, Dortho +918888788880
Contact: Smita S Bhoyar, B A M S PGCR 9372620569

Chaitanya Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin S Jamadar, D ORTHO    +918888788880   
Contact: Smita S Bhoyar, BAMS.PGCR    9372620569   
Sponsors and Collaborators
Chaitanya Hospital, Pune
  More Information

No publications provided

Responsible Party: Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune Identifier: NCT01834040     History of Changes
Other Study ID Numbers: 00102
Study First Received: February 26, 2013
Last Updated: April 15, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
Duchenne Muscular Dystrophy
Muscular Dystrophy

Additional relevant MeSH terms:
Muscular Dystrophy, Duchenne
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn processed this record on August 21, 2014