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

September 6, 2010
January 2, 2012
August 2009
July 2010   (final data collection date for primary outcome measure)
Pain relief [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain
Same as current
Complete list of historical versions of study NCT01207661 on ClinicalTrials.gov Archive Site
Pain relief [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
decrease the patient pain in VAS scale
Same as current
Not Provided
Not Provided
 
Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint
Mesenchymal Stem Cells Transplantation for Articular Cartilage Resurfacing in Patient With Osteoarthritis of Knee Joint

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
Biological: Mesenchymal Injection
Intra Articular Injection of Mesenchymal cells to the knee joint
Other Name: Cell Injection
Experimental: Mesenchymal Injection
Intra Articular injection in Patients with osteoarthritis of knee joint
Intervention: Biological: Mesenchymal Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
November 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01207661
Royan-Bone-002
Yes
Royan Institute
Royan Institute
Not Provided
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
Royan Institute
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP