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This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ex- vivo cultured adult allogeneic MSCs | Experimental | Single intraarticular dose of allogeneic MSCs suspended in 2-4ml Plasmalyte A followed by 2 ml of Hyaluronan |
|
| Plasmalyte-A | Placebo Comparator | Single intraarticular dose of 2ml Plasmalyte |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ex- vivo cultured adult allogeneic MSCs | Biological | Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of patients with adverse events as a measure of safety and tolerability |
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score | 2 years | |
| Change from baseline in WOMAC OA stiffness index | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vikas Agarwal, MD., DM | Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences | Principal Investigator |
| Vivek Pandey, MS | Department of Orthopedics, Kasturba Medical College | Principal Investigator |
| Naresh Shetty, MS | Department of Orthopedics, M. S. Ramaiah Memorial Hospital | Principal Investigator |
| Shrikant Wagh, MD | Jehangir Hospital | Principal Investigator |
| Bhibas Dasgupta, MS | Seth G. S. Medical College and KEM Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, M. S. Ramaiah Memorial Hospital | Bangalore | Karnataka | 560054 | India | ||
| Department of Orthopedics, Kasturba Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27993154 | Derived | Gupta PK, Chullikana A, Rengasamy M, Shetty N, Pandey V, Agarwal V, Wagh SY, Vellotare PK, Damodaran D, Viswanathan P, Thej C, Balasubramanian S, Majumdar AS. Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel(R)): preclinical and clinical trial in osteoarthritis of the knee joint. Arthritis Res Ther. 2016 Dec 20;18(1):301. doi: 10.1186/s13075-016-1195-7. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
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| Plasmalyte-A | Biological | Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan |
|
| Change from baseline in WOMAC OA composite index |
| 2 years |
| Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain) | 2 years |
| Change from baseline in radiographic (X-ray) findings of knee | 2 years |
| Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI | 2 years |
| Change from baseline in arthritis pain scores on the visual analogue scale | 2 years |
| Reduction in the intake of analgesic tablets from baseline | 2 years |
| Manipal |
| Karnataka |
| 576 104 |
| India |
| Seth G. S. Medical College and KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| Jehangir Hospital | Pune | Maharashtra | 411001 | India |
| Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences | Lucknow | Uttar Pradesh | 226 014 | India |