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| Name | Class |
|---|---|
| The Institute of Traumatology and Orthopedics of NAMS of Ukraine | UNKNOWN |
| Kyiv City Clinical Hospital № 6 | UNKNOWN |
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To define the clinical effects of intra-articular transplantation of bone-marrow-derived (BM-MMSCs) and placenta-derived multipotent mesenchymal stem / stromal cells (P-MMSCs) for knee osteoarthritis.
Multipotent mesenchymal stem / stromal cells (MMSCs) of different origin are the novel therapeutic agents that can slow down cartilage degeneration, improve reparation and ultimately prevent joint prosthetics. MSCs are capable to direct differentiation into chondrocytes, produce cytokines and growth factors with immunomodulatory and anti-inflammatory effects, stimulate angiogenesis, as well as induce chemotaxis of endogenous progenitors. Bone marrow-derived and placenta-derived MMSCs can be considered the most promising source for cell therapy of joints disorders according to availability, safety and expected therapeutic efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid (HA) + P-MMSCs | Experimental | Experimental Group 1: Three intra-articular injection of allogeneic P-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients |
|
| Hyaluronic Acid (HA) + BM-MMSCs | Experimental | Experimental Group 2: Three intra-articular injection of autologous BM-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients |
|
| Hyaluronic Acid (HA) | Active Comparator | Three intra-articular injection of 20 mg Hyaluronic Acid - 15 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placenta-derived MMSCs | Biological | Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and changes in physical examinations, vital signs and the results of clinical lab tests. | Treatment-related adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function improvement measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). | Change in joint function from baseline WOMAC assessment. The WOMAC used a scoring scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). The higher the score, the higher the amount of pain, stiffness, and a high level of functional limitations. | 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Nemtinov, MD | Contact | +380442079207 | nemtinov@stemcellclinic.com | |
| Vitalii Kyryk, MD, PhD | Contact | +380442079207 | kyryk@stemcellclinic.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Nemtinov, MD | Institute of Cell Therapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cell Therapy | Recruiting | Kyiv | 04073 | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40281581 | Derived | Holiuk Y, Birsa R, Bukreieva T, Nemtinov P, Kyryk V, Ustymenko A, Mazevych V, Sokolov M, Lobyntseva G, Shablii V. Effectiveness and safety of multiple injections of human placenta-derived MSCs for knee osteoarthritis: a nonrandomized phase I trial. BMC Musculoskelet Disord. 2025 Apr 26;26(1):418. doi: 10.1186/s12891-025-08664-2. |
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Experimental: HA + stem cells therapy Experimental Group 1: three intra-articular injection of allogeneic P-MMSCs with up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients Experimental Group 2: three intra-articular injection of autologous BM-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients Control Group: three intra-articular injection of 20 mg Hyaluronic Acid, no cell therapy - 15 patients
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| Bone marrow-derived MMSCs | Biological | Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells |
|
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| Hyalgan 20 mg in 2 ML Prefilled Syringe | Drug | Hyaluronic Acid 20 mg |
|
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| Radiographic evidence. Whole-Organ Magnetic Resonance Imaging Score (WORMS) | Change in cartilage thickness of the knee using MRI | 12 months |
| Quality of Life (QOL) assessment | Change in scores on the QOL | 12 months |
| The Visual Analog Scale (VAS) assessment | VAS - measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "worst imaginable pain" (score of 10). | 12 months |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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