Clinical trial NCT01504464: The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis
Official title: Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: knee joint osteoarthritis mesenchymal stem cell
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2012-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: physical function improvement
timeFrame: 2weeks
measure: change in pain density
timeFrame: 2 weeks
Secondary outcomes:
measure: joint swelling
timeFrame: 3months
measure: joint erythema
timeFrame: 3months
measure: deterioration of joint function
timeFrame: 3months
measure: Allergic reactions
timeFrame: 3months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan Cell therapy Center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: scientist
name: Mohsen Emadeddin, MD
role: PRINCIPAL_INVESTIGATOR
References: