Safety and Efficacy of BMMNCin Patients With Mental Retar... | NCT01908400

Studies
Safety and Efficacy of BMMNCin Patients With Mental Retardation

NCT01908400

Sponsor

Chaitanya Hospital, Pune

Status

Unknown status

Last Update Posted

Sep 17, 2014Estimated

Enrollment

15Estimated

Phase

Phase 1Phase 2

Conditions

Mental Retardation

Interventions

Intravenous transfer of BMMNC

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

Sep 2014

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Jul 23, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 25, 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

Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMMNCs	Other	Intravenous transfer of (BMMNCs)	Biological: Intravenous transfer of BMMNC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous transfer of BMMNC	Biological	Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Binet-Kamat Test	CHANGE in IQ as measured by Binet-Kamat Test	1 YEAR

Secondary Outcomes

Measure	Description	Time Frame
Vineland Social Maturity Scale	CHANGE in Social Quotient as measured by Vineland Social Maturity Scale	baseline and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age limit: 5 -50
Primary diagnosis of mental retardation (IQ < 70)
willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
Advanced age that may produce deteriorating cognitive or motor functioning
Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
Poor general health

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sachin P Jamadar, D.Ortho	Contact	918888788880		sac2751982@gmail.com

Overall Officials

Name	Affiliation	Role
ANANT E BAGUL, MS ORTHO	Chaitanya Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaitanya Hospital	Recruiting	Pune	Maharashtra	411030	India

Condition Browse Module

MeSH Terms

ID	Term
D008607	Intellectual Disability

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided