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
Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical-cord mesenchymal stromal cells | Experimental | Umbilical-cord mesenchymal stromal cells (UC-MSCs) Allogeneic UC-MSCs 20 x 10e6 diluted on 3 mL of saline solution + 5% of Plasma AB Arm 2a: single infusion group. UC-MSCs at 0 month Arm 2b: double infusion group. UC-MSCs at 0 and 6 months |
|
| Hyaluronic Acid (HA) | Active Comparator | Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical-cord mesenchymal stromal cells | Biological | Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who experience an adverse event | according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function improvement measured by WOMAC OA index | 12 months | |
| Change in pain density measured by Visual analogue scale (VAS) | 12 months | |
| QoL improvement measured by SF-36 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jose Matas, MD | Universidad de Los Andes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de los Andes | Santiago | Chile |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 17, 2019 | |
| Reset | Apr 12, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 17, 2019 | Apr 12, 2019 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hyaluronic Acid | Drug | Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months |
|
|
| 12 months |
| Changes in WORMS scale measured by knee MRI | 12 months |