A Clinical Study to Evaluate the Safety and Efficacy of M... | NCT01877759

Studies
A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis

NCT01877759

Sponsor

Chaitanya Hospital, Pune

Status

Unknown status

Last Update Posted

Oct 9, 2013Estimated

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

Liver Cirrhosis

Interventions

Mesenchymal 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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jun 12, 2013

First Submission Date that Met QC Criteria

Jun 13, 2013

First Posted Date

Jun 14, 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

Oct 8, 2013

Last Update Posted Date

Oct 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, PunePrincipal Investigator

Lead Sponsor

Chaitanya Hospital, PuneOTHER

Collaborators

Not provided

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

Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the liver), or by blockage of biliary system such that the liver undergoes progressive scarring that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. For this condition of disease the liver transplantation is one of the only effective therapies available ,but due to lack of donors, surgical complications, rejection, and high cost are it's serious problems.

Presently stem cells are used to be a one of the treatment for the same. So our approach is to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis .

Detailed Description

In this study, the patients with liver cirrhosis will undergo administration of human Mesenchymal stem cell MSCs intravenously for these patients.To observe the results Liver function will be monitored by serum analysis.The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 6th days to 1 years post-transfusion.Also the to see Improvement evaluation by MELD score ,Quality of life ,Child-Pugh score will be done .

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenchymal stem cell	Other	hUMAN MESENCHYMAL STEM CELLS	Biological: Mesenchymal stem cell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal stem cell	Biological	Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow & umbilical cord , IN 6 divided doses , at interval of 1 week .	Mesenchymal stem cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in Liver function tests	1) Improvement of Liver Function tests liver functions( Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)),international normalized ratio (INR) in Liver Cirrhosis Patients	6 month

Secondary Outcomes

Measure	Description	Time Frame
Changes in liver function according to Child-Pugh		6 MONTH
Changes in liver function according to MELD Score		6 MONTH
Improvement in QUALITY OF LIFE SCALE (QOL)

Other Outcomes

Measure	Description	Time Frame
Changes of any clinical symptoms like abdominal distension, appetite, debilitation		6 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria

25 -65 Ages Eligible for Study
Clinical diagnosis of liver cirrhosis
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.
Expecting lifetime is over three years
Ready to come all visits

Exclusion Criteria:

History of life threatening allergic or immune-mediated reaction
Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis
Malignancies
Sepsis
Vital organs failure
Pregnant or lactating women
Subject who has been transplanted recently
If the investigator or treating physician feels that the Subject with any disease or condition would interfere with the trial or the safety of patient

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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, MS ORTHO	Chaitanya Hospital	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided