Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (KDD&MSV)
This study is ongoing, but not recruiting participants.
Sponsor:
Red de Terapia Celular
Collaborators:
Fundacion Teknon, Centro Medico Teknon, Barcelona
Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid
Scientific Park Foundation, University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Institut de Terapia Regenerativa Tissular
EGARSAT Suma Intermutual, Barcelona, Spain
CETIR Sant Jordi, Barcelona, Spain
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT01183728
First received: August 13, 2010
Last updated: April 28, 2012
Last verified: April 2012
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Purpose
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothesis proposes that MSV antiinflammatory effect will help healing of articular cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging procedures. The study of quantitative changes in structure and composition of cartilage determined by T2-weighted MRI (Cartigram ) will be performed at 6, 12 and 24 months. Pain will be assessed by visual analogue scale (VAS), Oswestry disability index and evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12 and 24 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Degenerative Disease Knee Arthrosis Knee Osteoarthritis Osteoarthritis, Knee |
Other: Autologous bone marrow mesenchymal stem cells (MSV) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Regeneration of Articular Cartilage in Grade II, III and IV Knee Osteoarthritis by Intraarticular Injection of Autologous Bone Marrow Stem Cells Expanded ex Vivo With a GMP Procedure Developed by IBGM-Valladolid (MSV) |
Resource links provided by NLM:
Further study details as provided by Red de Terapia Celular:
Primary Outcome Measures:
- To evaluate the feasibility and safety of the implementation of MSV in the treatment of osteoarthritis of the knee. [ Time Frame: 0, 3, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]Clinical review, questionaires (VAS, Oswestry disbility index, sf36 life quality)
Secondary Outcome Measures:
- Indication of efficacy [ Time Frame: 0, 3, 6, 12, 24 months ] [ Designated as safety issue: Yes ]Clinical exploration, questionaires (VAS, Oswestry, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MSV autologous transplantation
Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection
|
Other: Autologous bone marrow mesenchymal stem cells (MSV)
Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection.
Other Name: MSV, mesenchymal stem cells by IBGM-Valladolid protocol.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 76 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 75 or under 18 years or legally dependent
- Any sign of infection
- Positive serology for HIV-1 orHIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
- 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: NCT01183728
Locations
| Spain | |
| Teknon Medical Center, ITRT | |
| Barcelona, Spain, 08022 | |
| Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid | |
| Valladolid, Spain, 47003 | |
Sponsors and Collaborators
Red de Terapia Celular
Fundacion Teknon, Centro Medico Teknon, Barcelona
Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid
Scientific Park Foundation, University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Institut de Terapia Regenerativa Tissular
EGARSAT Suma Intermutual, Barcelona, Spain
CETIR Sant Jordi, Barcelona, Spain
Investigators
| Principal Investigator: | Luis Orozco, MD, PhD | Fundacion Teknon |
| Study Director: | Ana Sanchez, MD, PhD | IBGM, University of Valladolid |
| Study Director: | Robert Soler, MD | Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon |
| Study Director: | Javier Garcia-Sancho, MD, PhD | IBGM, University of Valladolid |
More Information
Additional Information:
No publications provided
| Responsible Party: | Red de Terapia Celular |
| ClinicalTrials.gov Identifier: | NCT01183728 History of Changes |
| Other Study ID Numbers: | TerCel001, Eudra-CT 2009-017405-11, Protocol Code |
| Study First Received: | August 13, 2010 |
| Last Updated: | April 28, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ministry of Health and Consumption |
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 |
Additional relevant MeSH terms:
|
Joint Diseases Osteoarthritis Osteoarthritis, Knee |
Musculoskeletal Diseases Arthritis Rheumatic Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
