Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells
Overview[ - collapse ][ - ]
| Purpose | In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year. |
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| Condition | Osteoarthritis, Knee Knee Arthrosis Knee Osteoarthritis |
| Intervention | Other: Injection of Mesenchymal Stromal Cells Drug: Hyaluronic Acid |
| Phase | Phase 1/Phase 2 |
| Sponsor | Red de Terapia Celular |
| Responsible Party | Red de Terapia Celular |
| ClinicalTrials.gov Identifier | NCT01586312 |
| First Received | April 23, 2012 |
| Last Updated | May 18, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 23, 2012 |
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| Last Updated Date | May 18, 2013 |
| Start Date | April 2012 |
| Estimated Primary Completion Date | December 2013 |
| Current Primary Outcome Measures | Number of participants with adverse events as a measure of safety and tolerability [Time Frame: Up to one year] [Designated as safety issue: Yes]Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells |
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| Official Title | Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Bone Marrow Expanded ex Vivo With the Procedure Developed by the Instituto de Biología y Genética Molecular (IBGM) de Valladolid |
| Brief Summary | In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
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| Intervention | Other: Injection of Mesenchymal Stromal Cells Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency Other Names:
Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml) Other Names: Hyaluronic acid, durolane, CE mark:516407 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 30 |
| Estimated Completion Date | December 2013 |
| Estimated Primary Completion Date | September 2013 |
| Eligibility Criteria | Inclusion Criteria: - Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers. - Chronic knee pain with mechanical characteristics. - No local or systemic septic process. - Haematological and biochemical analysis without significant alterations that contraindicate treatment. - Informed written consent of the patient. - The patient is able to understand the nature of the study Exclusion Criteria: - Age over 65 or under 18 years or legally dependent - Previous intervention in the affected knee - Signs of torn ligaments by MRI - Intra-articular treatments in the last 6 months - Any sign of infection - Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results. - Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2). - Women who are pregnant or intend to become pregnant or breast-feeding - Neoplasia Immunosuppressive states - Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study. - Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Javier Garcia-Sancho, MD, PhD 0034 983 184830 jgsancho@ibgm.uva.es |
| Location Countries | Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01586312 |
|---|---|
| Other Study ID Numbers | TerCel004 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Red de Terapia Celular |
| Study Sponsor | Red de Terapia Celular |
| Collaborators | University of Valladolid Sanidad de Castilla y Leon (SACYL) Centro Medico Teknon |
| Investigators | Study Chair: Javier García-Sancho, MD, PhD University of Valladolid, Scientific ParkStudy Director: Aurelio Vega, MD,PhD Hospital Clinico Universitario, ValladolidStudy Director: Luis Orozco, MD, PhD Centro Médico Teknon, BarcelonaStudy Director: Ana Sanchez, MD, PhD Director, Cell Production Unit, Parque Científico UVa |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| Centro Medico Teknon | Barcelona, Spain, 08022 Contact: Luis Orozco, MD, PhD | 0034 93 290 6042 | lluis.orozco@itrt.esPrincipal Investigator: Luis Orozco, MD, PhD Recruiting |
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| Hospital Clinico Universitario | Valladolid, Spain, 47003 Contact: Aurelio Vega, MD, PhD | 0034 983 420400276 | avegacastrillo@live.comPrincipal Investigator: Aurelio Vega, MD,PhD Recruiting |