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
A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLT low-dose | Experimental | Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee |
|
| CLT medium-dose | Experimental | Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee |
|
| CLT high-dose | Experimental | Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord derived-mesenchymal stromal cells | Biological | Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC score | 6 months | |
| Change in VAS score | 6 months | |
| Changes in structural joint assessment by MRI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Espinoza, MD | Contact | 56226181008 | fespinoza@uandes.cl | |
| Roberto Bobadilla | Contact | 56226181000 | rbobadilla@c4c.cl |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Espinoza, MD | CMO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universidad de los Andes | Recruiting | Santiago | XIII | 7620001 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38366909 | Derived | Matas J, Garcia C, Poblete D, Vernal R, Ortloff A, Luque-Campos N, Hidalgo Y, Cuenca J, Infante C, Cadiz MI, Khoury M, Luz-Crawford P, Espinoza F. A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis. Stem Cells Transl Med. 2024 Mar 15;13(3):193-203. doi: 10.1093/stcltm/szad088. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| D012216 |
| Rheumatic Diseases |