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

NCT ID: NCT01504464

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-10-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

mesenchymal stem cell

Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection.

Group Type: EXPERIMENTAL

mesenchymal stem cell

Intervention Type: BIOLOGICAL

intra articular injection of mesenchymal stem cell

placebo

The patients who are in control group and underwent placebo injection.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: BIOLOGICAL

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Interventions

mesenchymal stem cell

intra articular injection of mesenchymal stem cell

Intervention Type: BIOLOGICAL

Placebo

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Intervention Type: BIOLOGICAL

Other Intervention Names

stem cell transplantation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of Royan Cell therapy Center

Mohsen Emadeddin, MD

Role: PRINCIPAL_INVESTIGATOR

scientist

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

Other Identifiers

Royan-Bone-010

Identifier Type: -

Identifier Source: org_study_id