Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cell | Experimental | Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection. |
|
| placebo | Experimental | The patients who are in control group and underwent placebo injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cell | Biological | intra articular injection of mesenchymal stem cell |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Iran |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Patients with knee joint osteoarthritis who underwent intra articular placebo 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 |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |