Stem Cell Therapy in Duchenne Muscular Dystrophy | NCT02241434

Studies
Stem Cell Therapy in Duchenne Muscular Dystrophy

NCT02241434

Sponsor

Neurogen Brain and Spine Institute

Status

Withdrawn

Last Update Posted

Oct 25, 2018Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Duchenne Muscular Dystrophy

Interventions

Stem Cell

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Sep 12, 2014

First Posted Date

Sep 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2018

Last Update Posted Date

Oct 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stem Cell	Experimental	bone marrow mononuclear cell transplantation	Biological: Stem Cell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stem Cell	Biological	Intrathecal autologous bone marrow mononuclear cell transplantation	Stem Cell

Measure	Description	Time Frame
Manual Muscle Testing		1 year

Measure	Description	Time Frame
Brooke and Vignos Scale		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurogen brain and spine institute		Navi Mumbai	Maharashtra	400706	India

Condition Browse Module

MeSH Terms

ID	Term
D020388	Muscular Dystrophy, Duchenne

Ancestor Terms

ID	Term
D009136	Muscular Dystrophies
D020966	Muscular Disorders, Atrophic
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided