Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01207661
First received: September 6, 2010
Last updated: January 2, 2012
Last verified: April 2009
  Purpose

Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by the investigators research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.


Condition Intervention Phase
Osteoarthritis
Biological: Mesenchymal Injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells Transplantation for Articular Cartilage Resurfacing in Patient With Osteoarthritis of Knee Joint

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain


Secondary Outcome Measures:
  • Pain relief [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    decrease the patient pain in VAS scale


Enrollment: 6
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal Injection
Intra Articular injection in Patients with osteoarthritis of knee joint
Biological: Mesenchymal Injection
Intra Articular Injection of Mesenchymal cells to the knee joint
Other Name: Cell Injection

Detailed Description:

Mesenchymal stem cells are pluripotent cells that can be obtained from various tissues .They have shown capabilities to differentiate into bone,cartilage,muscle,and adipose tissue, representing a new clinical strategy in regenerative medicine.An increasing number of reports have demonstrated effectiveness of percutaneous intra-articular infusion of MSCs in arthritic disease. In this study we perform a single intra articular injection of cultured mesenchymal stem cells in patients suffering from osteoarthritis, with the aim to assess its clinical safety and efficacy.Patients are assessed for response with MRI, X-Ray examination, WOMAC osteoarthritis index,VAS, and SF36 2,4,8 weeks and 6, and 12 months post infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients not pregnant or lactating.
  • Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy
  • Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee.
  • Diagnosis must be based on magnetic resonance imaging.
  • Both genders
  • Age:18-65 years

Exclusion Criteria:

  • Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease.
  • Known allergic reaction to components of study treatment and/or study injection procedure
  • Patients infected with hepatitis B,C or HIV.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207661

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Mohammad reza Baghban Eslami Nejad, PhD Scientific Board
Principal Investigator: Mohssen Emadeddin, MD Orthopadic Investigator
Principal Investigator: Nasser Aghdami, MD,PhD Head of Regeneration center
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01207661     History of Changes
Other Study ID Numbers: Royan-Bone-002
Study First Received: September 6, 2010
Last Updated: January 2, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Mesenchymal cells
osteoarthritis
intra articular injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014