Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells - Full Text View

Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (KDD&MSV)

This study is ongoing, but not recruiting participants.

First Received on August 13, 2010. Last Updated on April 28, 2012 History of Changes

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

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:

MedlinePlus related topics: Joint Disorders Osteoarthritis

U.S. FDA Resources

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.

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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:

Spanish Cell Therapy Network This link exits the ClinicalTrials.gov site

Cell application, ITRT-Centro Médico Teknon This link exits the ClinicalTrials.gov site

Cell production, Instituto de Biologia y Genetica Molecular (IBGM) University of Valladolid This link exits the ClinicalTrials.gov site

osteoarthritis, knee This link exits the ClinicalTrials.gov site

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 May 24, 2012