Safety and Efficacy of Bone Marrow MNC for the Treatment... | NCT01832454

Studies
Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years

NCT01832454

Sponsor

Chaitanya Hospital, Pune

Status

Unknown status

Last Update Posted

Sep 17, 2014Estimated

Enrollment

100Estimated

Phase

Phase 2Phase 3

Conditions

Cerebral Palsy

Interventions

Intra thecal inj of autologous MNC

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Nov 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Feb 26, 2013

First Submission Date that Met QC Criteria

Apr 12, 2013

First Posted Date

Apr 16, 2013Estimated

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

Sep 16, 2014

Last Update Posted Date

Sep 17, 2014Estimated

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

This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Detailed Description

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intra thecal inj of autologous MNC	Other	Intra thecal inj of autologous MNC	Other: Intra thecal inj of autologous MNC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intra thecal inj of autologous MNC	Other	Intra thecal inj of autologous MNC	Intra thecal inj of autologous MNC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.	- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.	6 months

Secondary Outcomes

Measure	Description	Time Frame
-Improvement in IQ by using Benit Kamat scale.	-Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.	6 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
Able to Comprehend and give written informed consent form for the study
willing to come to the hospital for follow up visits as per the protocol requirements

Exclusion Criteria:

History of meningitis,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
Hemodynamically unstable patients
history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
peripheral Muscular dystropy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anant E Bagul, M.S.	chaitanya stem cell centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaitnany Hospital	Recruiting	Pune	Maharashtra	411009	India

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided