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Allogeneic Mesenchymal Stem Cells in Osteoarthritis

NCT01453738 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-05-12

No results posted yet for this study

Summary

This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.

Conditions

  • Osteoarthritis of Knee

Interventions

BIOLOGICAL

Ex- vivo cultured adult allogeneic MSCs

Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan

BIOLOGICAL

Plasmalyte-A

Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan

Sponsors & Collaborators

  • Stempeutics Research Pvt Ltd

    lead INDUSTRY

Principal Investigators

  • Vikas Agarwal, MD., DM · Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences

  • Vivek Pandey, MS · Department of Orthopedics, Kasturba Medical College

  • Naresh Shetty, MS · Department of Orthopedics, M. S. Ramaiah Memorial Hospital

  • Shrikant Wagh, MD · Jehangir Hospital

  • Bhibas Dasgupta, MS · Seth G. S. Medical College and KEM Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453738 on ClinicalTrials.gov