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

NCT01504464 | Completed Phase 2 DMC

• 1 other identifier: Royan-Bone-010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

knee joint osteoarthritis mesenchymal stem cell

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• joint swelling

  3months

• joint erythema

  3months

• deterioration of joint function

  3months

• Allergic reactions

  3months

Study Arms (2)

mesenchymal stem cell

EXPERIMENTAL

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

Biological: mesenchymal stem cell

placebo

EXPERIMENTAL

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

Biological: Placebo

Interventions

mesenchymal stem cell BIOLOGICAL

intra articular injection of mesenchymal stem cell

Also known as: stem cell transplantation

mesenchymal stem cell

Placebo BIOLOGICAL

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis diagnosed by MRI

You may not qualify if:

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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

  Head of Royan Cell therapy Center

  STUDY DIRECTOR

• Mohsen Emadeddin, MD

  scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 5, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2015-11

Locations

IR (1)