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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017624-72 | EudraCT Number |
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Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
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:
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid 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 and cultured ex vivo under local anesthesia and sedation.
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:
Inclusion Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hialuronic acid | Active Comparator | Single intraarticular injection of Hyaluronic acid (Hyal One) |
|
| Hyaluronic acid and MSC 10 | Active Comparator | Single intraarticular injection of Hyaluronic acid (Hyal One) 10 million Bone marrow mesenchimal stem cells |
|
| Hyaluronic acid AND MSC 100 | Active Comparator | Single intraarticular injection of Hyaluronic acid (Hyal One) 100 million Bone marrow mesenchimal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Drug | Single intraarticular injection of Hyaluronic acid (Hyal One) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Visual analogue scale (VAS) | Baseline Visual analogue scale (VAS) | prior to the initial dose on 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). | Prior to the intervention on day 1 |
| Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC). | Prior to the intervention on day 1 Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC). | Prior to the intervention on day 1 |
| Baseline SF-36 value | Prior to the intervention on day 1 SF-36 value | Prior to the intervention on day 1 |
| Baseline euroquol 5D value | Pretreatment euroquol 5D value | Prior to the intervention on day 1 |
| Baseline Lequesne index | Prior to the intervention on day 1 Lequesne index | Prior to the intervention on day 1 |
| Baseline femorotibial distance | Prior to the intervention femoritibial distance on rosenberg x-ray view | Prior to the intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Lamo-Espinosa, MD | Clinica Universidad de Navarra | Principal Investigator |
| Felipe Prosper, MD PhD | Clinica Universidad de Navarra | Study Director |
| Juan Blanco, MD PhD | University of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Traumatology department. Complejo Hospitalario de Salamanca | Salamanca | Castille and LeĂłn | 37007 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34895259 | Derived | Lamo-Espinosa JM, Prosper F, Blanco JF, Sanchez-Guijo F, Alberca M, Garcia V, Gonzalez-Vallinas M, Garcia-Sancho J. Long-term efficacy of autologous bone marrow mesenchymal stromal cells for treatment of knee osteoarthritis. J Transl Med. 2021 Dec 11;19(1):506. doi: 10.1186/s12967-021-03160-2. | |
| 30064455 | Derived |
| Label | URL |
|---|---|
| University clinic of navarre trial information | View source |
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|
| 10 million Bone marrow mesenchimal stem cells | Biological | 10 million of Bone marrow mesenchimal stem cells |
|
| 100 million Bone marrow mesenchimal stem cells | Biological | 100 million of Bone marrow mesenchimal stem cells |
|
During the follow up |
| Follow up |
| Visual analogue scale (VAS) at on 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 |
| Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month | Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month | 1 month |
| Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 3 month | Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month | 3 months |
| Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month | Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month | 6 months |
| Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months | Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months | 12 months |
| SF-36 value at 1 month | SF-36 value | 1 month |
| SF 36 value at 3 months | SF 36 value at 3 months | 3 months |
| SF 36 value at 6 months | SF 36 value at 6 months | 6 months |
| SF 36 value at 12 months | SF 36 value at 12 months | 12 months |
| Euroquol 5D value at 1 month | Euroquol 5D value at 1 month | 1 MOnth |
| Euroquol 5D value at 3 months | Euroquol 5D value at 3 months | 3 months |
| Euroquol 5D value at 6 months | Euroquol 5D value at 6 months | 6 months |
| Euroquol 5D value at 12 months | Euroquol 5D value at 12 months | 12 months |
| Lequesne index at 1 month | Lequesne index at 1 month | 1 month |
| Lequesne index at 3 months | Lequesne index at 3 months | 3 months |
| Lequesne index at 6 months | Lequesne index at 6 months | 6 months |
| Lequesne index at 12 months | Lequesne index at 12 months | 12 months |
| Femorotibial distance at 6 months | Femorotibial distance at 6 months | 6 months |
| Femorotibial distance at 12 months | Femorotibial distance at 12 months | 12 months |
| Baseline MRI WORMS protocol | Prior to the intervention MRI WORMS protocol | Prior to the intervention |
| MRI WORMS protocol score at 6 months | MRI WORMS protocol score at 6 months | 6 months |
| MRI WORMS protocol score at 12 months | MRI WORMS protocol score at 12 months | 12 months |
| Orthopaedic and traumatology department. ClĂnica Universidad de Navarra |
| Pamplona |
| Navarre |
| 31008 |
| Spain |
| Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Lopez-Elio S, Andreu E, Sanchez-Guijo F, Aquerreta JD, Bondia JM, Valenti-Azcarate A, Del Consuelo Del Canizo M, Villaron EM, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2018 Jul 31;16(1):213. doi: 10.1186/s12967-018-1591-7. |
| 27565858 | Derived | Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2. |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| 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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