Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral... | NCT02242071

Studies
Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

NCT02242071

Sponsor

Neurogen Brain and Spine Institute

Status

Withdrawn

Last Update Posted

Oct 25, 2018Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Amyotrophic Lateral Sclerosis

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Withdrawn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

Dec 2008

Primary Completion Date

Mar 2015Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Sep 13, 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 effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amyotrophic Lateral Sclerosis Functional rating scale-revised		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.
Age 18-80 years

Exclusion Criteria:

HIV/HBV/HCV
Malignancies
Bleeding tendencies
Pneumonia
Renal failure
Severe liver dysfunction
Severe anemia [hb < 8]
Any bone marrow disorder
Space occupying lesion in brain
Pregnancy and lactation
Other acute medical conditions/infections such as respiratory infection and pyrexia
left ventricular ejection fraction < 25%
Patient on artificial ventilatory support

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D016472	Motor Neuron Disease

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases

Browse Leaves

Not provided

Browse Branches

Not provided