NCT02241434

Brief Summary

The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

January 1, 2009

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

7 years

First QC Date

September 12, 2014

Last Update Submit

October 23, 2018

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne muscular dystrophyAutologous Bone marrow Mononuclear cell therapyStem Cells

Outcome Measures

Primary Outcomes (1)

  • Manual Muscle Testing

    1 year

Secondary Outcomes (1)

  • Brooke and Vignos Scale

    1 year

Study Arms (1)

Stem Cell

EXPERIMENTAL

bone marrow mononuclear cell transplantation

Biological: Stem Cell

Interventions

Stem CellBIOLOGICAL

Intrathecal autologous bone marrow mononuclear cell transplantation

Stem Cell

Eligibility Criteria

Age3 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age group of 3-25 years
  • Duchenne muscular dystrophy diagnosed on the basis of clinical presentation

You may not qualify if:

  • presence of respiratory distress
  • presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
  • malignancies
  • acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
  • pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogen brain and spine institute

Navi Mumbai, Maharashtra, 400706, India

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

January 1, 2009

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

IN(1)