Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006036-23 | EudraCT Number |
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
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF®) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
The autologous mesenchymal stem cells are obtained from the iliac crest under local anesthesia and sedation. They are cultured ex vivo The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
All patients met the following inclusion and exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma (PRGF) | Active Comparator | Platelet Rich plasma (PRGF) 3 intraarticular onjections sepataded by 7 days. |
|
| BMMSC with Platelet Rich Plasma (PRGF) | Active Comparator | Single intraarticular injection of 100 million Bone marrow mesenchimal stem cells and three intraarticular injections of plateler Rich Plasma (PRGF) separatede by 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 million Bone marrow mesenchimal stem cells | Biological | 100 million Bone marrow mesenchimal stem cells with PRGF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS) | Baseline Visual analogue scale (VAS) prior to the initial dose on day 1 | Day 1 |
| Baseline value of knee injury and osteoarthritis outcome score (Koos). | Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos). | Day 1 |
| Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC). | Universities Osteoarthritis Index score (WOMAC). | Day 1 |
| Baseline SF-36 value | Baseline SF-36 value | Day 1 |
| Baseline euroquol 5D value | Pretreatment euroquol 5D value | Day 1 |
| Baseline Lequesne index | Prior to the intervention on day 1 Lequesne index | Day 1 |
| Baseline femorotibial distance | Prior to the intervention femoritibial distance on rosenberg x-ray view | Day 1 |
| Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| José Lamo-Espinosa, MD | Clinica Universidad de Navarra | Principal Investigator |
| Felipe Prosper, MD, PhD | ClÃnica Universidad de Navarra | Study Director |
| Juan Blanco, MD; PhD | Complejo Universitario de Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Salamanca | Salamanca | Castille and León | 37007 | Spain | ||
| Departamento CirugÃa Ortopédica y TraumatologÃa. Clinica Universidad de Navarra |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32948200 | Derived | Lamo-Espinosa JM, Blanco JF, Sanchez M, Moreno V, Granero-Molto F, Sanchez-Guijo F, Crespo-Cullel I, Mora G, San Vicente DD, Pompei-Fernandez O, Aquerreta JD, Nunez-Cordoba JM, Vitoria Sola M, Valenti-Azcarate A, Andreu EJ, Del Consuelo Del Canizo M, Valenti-Nin JR, Prosper F. Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis. J Transl Med. 2020 Sep 18;18(1):356. doi: 10.1186/s12967-020-02530-6. |
| Label | URL |
|---|---|
| University clinic of navarre trial information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Platelet Rich plasma (PRGF) | Biological | 3 injections of PRGF |
|
Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events During the follow up
| Follow up (up to 12 months) |
| Visual analogue scale (VAS) at 1 month | Visual analogue scale (VAS) at on month | 1 month |
| Visual analogue scale (VAS) at 3 months | Visual analogue scale (VAS) at 3 months | 3 months |
| Visual analogue scale (VAS) at 6 months | Visual analogue scale (VAS) at 6 months | 6 months |
| Visual analogue scale (VAS) at 12 months | Visual analogue scale (VAS) at 12 months | 12 months |
| Value of knee injury and osteoarthritis outcome score (Koos) at 1 month | Value of knee injury and osteoarthritis outcome score (Koos) at 1 month | 1 month |
| Value of knee injury and osteoarthritis outcome score (Koos) at 3 month | Value of knee injury and osteoarthritis outcome score (Koos) at 3 month | 3 Months |
| Value of knee injury and osteoarthritis outcome score (Koos) at 6 month | Value of knee injury and osteoarthritis outcome score (Koos) at 6 month | 6 months |
| Value of knee injury and osteoarthritis outcome score (Koos) at 12 months | Value of knee injury and osteoarthritis outcome score (Koos) at 12 months | 12 months |
| Pamplona |
| Navarre |
| 31008 |
| Spain |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided