Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)
This study is currently recruiting participants.
Verified April 2012 by Red de Terapia Celular
Sponsor:
Red de Terapia Celular
Collaborators:
Scientific Park Foundation, University of Valladolid
Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid
Sanidad de Castilla y Leon (SACYL)
Centro Medico Teknon
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT01586312
First received: April 23, 2012
Last updated: April 28, 2012
Last verified: April 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee Knee Arthrosis Knee Osteoarthritis |
Other: Injection of Mesenchymal Stromal Cells Drug: Hyaluronic Acid |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Red de Terapia Celular:
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, diability and quality of life at 0, 3, 6 and 12 months
Secondary Outcome Measures:
- Pain and disability evolution (WOMAC and SF-36 scores) [ Time Frame: up to one year ] [ Designated as safety issue: No ]Clinical review, questionaires for pain, diability and quality of life at 0, 3, 6 and 12 months.
- Evolution of cartilage degeneration by T2 relaxation measurements in MRI (Cartigram) [ Time Frame: up to one year ] [ Designated as safety issue: No ]Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilague degeneration
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Allogenic mesenchymal stromal cells
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
|
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:
|
|
Active Comparator: Hyaluronic acid (Durolane)
Intraarticular injection of hyaluronic acid (60 mg)
|
Drug: Hyaluronic Acid
Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
Other Name: Hyaluronic acid, durolane, CE mark:516407
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586312
Contacts
| Contact: Javier Garcia-Sancho, MD, PhD | 0034 983 184830 | jgsancho@ibgm.uva.es |
| Contact: Aurelio Vega, MD, PhD | 0034 983 420000 ext 276 | avegacastrillo@live.com |
Locations
| Spain | |
| Centro Medico Teknon | Recruiting |
| Barcelona, Spain, 08022 | |
| Contact: Luis Orozco, MD, PhD 0034 93 290 6042 lluis.orozco@itrt.es | |
| Principal Investigator: Luis Orozco, MD, PhD | |
| Sub-Investigator: Robert Soler, MD, PhD | |
| Hospital Clinico Universitario | Recruiting |
| Valladolid, Spain, 47003 | |
| Contact: Aurelio Vega, MD, PhD 0034 983 420400 ext 276 avegacastrillo@live.com | |
| Principal Investigator: Aurelio Vega, MD,PhD | |
| Sub-Investigator: Francisco Del Canto, MD | |
| Sub-Investigator: Miguel A Martin Ferrero, MD, PhD | |
Sponsors and Collaborators
Red de Terapia Celular
Scientific Park Foundation, University of Valladolid
Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid
Sanidad de Castilla y Leon (SACYL)
Centro Medico Teknon
Investigators
| Study Chair: | Javier García-Sancho, MD, PhD | University of Valladolid, Scientific Park |
| Study Director: | Aurelio Vega, MD,PhD | Hospital Clinico Universitario, Valladolid |
| Study Director: | Luis Orozco, MD, PhD | Centro Médico Teknon, Barcelona |
| Study Director: | Ana Sanchez, MD, PhD | Director, Cell Production Unit, Parque Científico UVa |
More Information
Additional Information:
Publications:
| Responsible Party: | Red de Terapia Celular |
| ClinicalTrials.gov Identifier: | NCT01586312 History of Changes |
| Other Study ID Numbers: | TerCel004, 2011-005321-51, EC11-309, MSV_allo |
| Study First Received: | April 23, 2012 |
| Last Updated: | April 28, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ministry of Health |
Keywords provided by Red de Terapia Celular:
|
Knee degenerative disease osteoarthritis gonarthrosis stem cell cellular therapy |
regenerative therapy Mesenchymal stem cells Bone marrow musculoskeletal Diseases Mesenchymal Stromal Cells (allogenic) |
Additional relevant MeSH terms:
|
Joint Diseases Osteoarthritis Osteoarthritis, Knee Musculoskeletal Diseases Arthritis Rheumatic Diseases |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012
