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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: Mesenchymal Injection

• Registration Number: NCT01207661
• Lead Sponsor: Royan Institute

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-08
• Primary Completion: 2010-07
• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Study Completion: 2010-11
• Last Update Submitted: 2012-01-02
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal Injection	Mesenchymal Injection	Intra Articular injection in Patients with osteoarthritis of knee joint

Primary Outcome Measures

Name	Time	Method
Pain relief	6 months	evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain

Secondary Outcome Measures

Name	Time	Method
Pain relief	6 months	decrease the patient pain in VAS scale

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of