NCT01834040

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,

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

February 26, 2013

Last Update Submit

September 16, 2014

Conditions

Muscular DystrophyDuchenne Muscular Dystrophy

Keywords

Duchenne Muscular DystrophyMuscular DystrophyMyopathy

Outcome Measures

Primary Outcomes (1)

  • Improvement of daily living scale.

    6 MONTH

Secondary Outcomes (1)

  • Improvement of Muscular dystrophy specific functional Rating scale

    6 Months

Study Arms (1)

intralesional and Intravenous

OTHER

Intralesional/ Intravenous of Autologous Stem cells.

Other: Intralesional/ Intravenous of Autologous Stem cells.

Interventions

Intralesional/ Intravenous of Autologous Stem cells.OTHER

Intralesional/ Intravenous of Autologous MNCs per dose

Also known as: Intralesional/ Intravenous of Autologous MNCs., Intralesional/ Intravenous of Autologous MNCs
intralesional and Intravenous

Eligibility Criteria

Age4 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411009, India

RECRUITING

MeSH Terms

Conditions

Muscular DystrophiesMuscular Dystrophy, DuchenneMuscular Diseases

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • ANANT E BAGUL, M.S

    CHAITANYA HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin S Jamadar, Dortho

CONTACT

+918888788880sac2751982@gmail.com

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
CO-Investigator

Study Record Dates

First Submitted

February 26, 2013

First Posted

April 17, 2013

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)