NCT02245711

Brief Summary

The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.

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 Dec 2010

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withdrawn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

December 1, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

4.1 years

First QC Date

September 12, 2014

Last Update Submit

October 23, 2018

Conditions

Limb Girdle Muscular Dystrophy

Keywords

Limb Girdle Muscular DystrophyAutologous Bone Marrow Mononuclear cell therapyStem Cell

Outcome Measures

Primary Outcomes (1)

  • Change in Functional Independence Measure (FIM) scale

    Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale.

    1 year

Secondary Outcomes (1)

  • Change in Manual Muscle Testing (MMT)

    1 year

Study Arms (1)

Stem Cell

EXPERIMENTAL
Biological: Stem Cell

Interventions

Stem CellBIOLOGICAL
Stem Cell

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age group of 15 years-60 years
  • limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
  • Electromyographic and Nerve Conduction velocity findings

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 Dystrophies, Limb-Girdle

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic 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 22, 2014

Study Start

December 1, 2010

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

IN(1)