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

Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Biological: Placebo; Biological: mesenchymal stem cell

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mesenchymal stem cell; Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection.	Biological: mesenchymal stem cell; intra articular injection of mesenchymal stem cell; Other Names: stem cell transplantation
Experimental: placebo; The patients who are in control group and underwent placebo injection.	Biological: Placebo; Patients with knee joint osteoarthritis who underwent intra articular placebo injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Principal Investigator: Mohsen Emadeddin, MD, Scientist

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: January 4, 2012
• First Posted (Estimate): January 5, 2012

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 15, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: knee joint osteoarthritis mesenchymal stem cell
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Royan-Bone-010