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Allogeneic Mesenchymal Stem Cells for Osteoarthritis

NCT01448434 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-05-12

No results posted yet for this study

Summary

This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint.

Conditions

  • Osteoarthritis of Knee Joint

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 Malaysia SDN BHD

    collaborator UNKNOWN

  • Stempeutics Research Pvt Ltd

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Muhammad Ali Noor Muhd Abdul Ghani, FRCS · KPJ Ampang Puteri Specialist Hospital

  • Dr. Ahmad Hisham Abd. Rashid, MD., MS · Clinical Research Centre Hospital Serdang

  • Dr. Suntharalingam Subramaniam, FRCS · Pantai Cheras Medical Centre

  • Dato' Dr. Ramli Baba, MS · Selayang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Malaysia

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 NCT01448434 on ClinicalTrials.gov