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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fundacion Teknon, Centro Medico Teknon, Barcelona
Instituto de Biologia y Genetica Molecular (IBGM)
Scientific Park Foundation (PCUVa)
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: June 19, 2014
Last verified: June 2014
  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
Osteoarthritis, Knee
Knee Degenerative Disease
Knee Osteoarthritis
Other: Autologous bone marrow mesenchymal stem cells (MSV)
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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: October 2014
Estimated Primary Completion Date: August 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)
Scientific Park Foundation (PCUVa)
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:
Publications:
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: June 19, 2014
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:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014