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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01504464
First received: January 3, 2012
Last updated: December 25, 2012
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Biological: mesenchymal stem cell
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • physical function improvement [ Time Frame: 2weeks ] [ Designated as safety issue: No ]
    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection.

  • change in pain density [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection.


Secondary Outcome Measures:
  • joint swelling [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
    Evaluation the joint swelling by physical examination after intra articular cell injection.

  • joint erythema [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
    Evaluation the joint erythem by physical examination after cell injection

  • deterioration of joint function [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
    Evaluation the deterioration of joint function by physical examination after intra articular cell injection.

  • Allergic reactions [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
    Evaluation the allergic reactions like skin rash,skin erythema,dyspenea by physical examination after cell injection


Enrollment: 40
Study Start Date: September 2010
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504464

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Royan Cell therapy Center
Principal Investigator: Mohsen Emadeddin, MD scientist
  More Information

No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01504464     History of Changes
Other Study ID Numbers: Royan-Bone-010
Study First Received: January 3, 2012
Last Updated: December 25, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
knee joint osteoarthritis mesenchymal stem cell

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014