The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: mesenchymal stem cell; Biological: Placebo

• Registration Number: NCT01504464
• Lead Sponsor: Royan Institute

Brief Summary

Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in patients with severe knee osteoarthritis.

Detailed Description

This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal stem cells will be isolated from bone marrow, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale.

Study Timeline

• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Study Start: 2012-10
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2016-05-15
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Osteoarthritis diagnosed by MRI

Exclusion Criteria

• Pregnancy or lactating
• Positive tests for HIV, HCV, HBV
• Active neurologic disorder
• End organ damage
• Uncontrolled endocrine disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cell	mesenchymal stem cell	Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection.
placebo	Placebo	The patients who are in control group and underwent placebo injection.

Primary Outcome Measures

Name	Time	Method
physical function improvement	2weeks	Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection.
change in pain density	2 weeks	Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection.

Secondary Outcome Measures

Name	Time	Method
joint swelling	3months	Evaluation the joint swelling by physical examination after intra articular cell injection.
deterioration of joint function	3months	Evaluation the deterioration of joint function by physical examination after intra articular cell injection.
Allergic reactions	3months	Evaluation the allergic reactions like skin rash,skin erythema,dyspenea by physical examination after cell injection
joint erythema	3months	Evaluation the joint erythem by physical examination after cell injection

Trial Locations

Locations (1)

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