Study Safety and Efficacy of Bone Marrow Derived Autologo... | NCT01832441

Studies
Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus.

NCT01832441

Sponsor

Chaitanya Hospital, Pune

Status

Unknown status

Last Update Posted

Sep 17, 2014Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Diabetes Mellitus.

Interventions

Intra thecal transplantation 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

Sep 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Apr 9, 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)

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 trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

Detailed Description

his study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transfer of autologous MNC intrathecally	Other	single arm Intra thecal transplantation of autologous MNC	Other: Intra thecal transplantation of autologous MNC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intra thecal transplantation of autologous MNC	Other	Intra thecal inj.of 100 millions MNC in 3 doses at 7 days interval	Transfer of autologous MNC intrathecally

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abolition or reduction of insulin by >50 percentage	- Abolition or reduction of insulin by >50 percentage of ABMSCT by 6 month	6 months

Secondary Outcomes

Measure	Description	Time Frame
Improvement in HbA1C levels	Improvement in HbA1C levels as compared to baseline by the end of 6 months .	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient should suffer from Diabetes Mellitus.
Willingness to undergo Bone Marrow derived Autologous cell Therapy.
Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion Criteria:

Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure. Alcohol and drug abuse / dependence. Patients with History of Hypertension and Hypersensitive.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

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
Smita S Bhoyar, B.A.M.S.PGCR	Contact	9372620569		drsmitabhoyar@rediff.com

Overall Officials

Name	Affiliation	Role
ANANT E BAGUL, M.S	CHAITANYA HOSPITAL	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

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