Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)

This study has been completed.
Sponsor:
Collaborators:
Fundacion Parque Cientifico de la Universidad de Valladolid
Universidad de Valladolid
Instituto de Biologia y Genetica Molecular (IBGM)
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: November 4, 2014
Last verified: November 2014
  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
Arthritis of Knee
Knee Osteoarthritis
Other: Allogenic mesenchymal stromal cells injection
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 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, disability and quality of life at 0, 3, 6 and 12 months


Secondary Outcome Measures:
  • Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores) [ Time Frame: up to one year ] [ Designated as safety issue: No ]

    Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.

    WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.

    SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.

    The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.

    LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).

    All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.

    Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales.


  • 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 cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.

    Mean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88.



Enrollment: 30
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogenic mesenchymal stromal cells injection
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: Allogenic mesenchymal stromal cells injection
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:
  • MSV
  • Mesenchymal Stem Cells
  • MSC
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 75 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
  • Present Infection (to be included in the study no signs of infection must be evidenced)
  • Congenital or acquired malformation resulting in significant deformity of the knee (varus<10º; valgus<20º) 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
  • Intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion
  • 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01586312

Locations
Spain
Centro Medico Teknon
Barcelona, Spain, 08022
Hospital Clinico Universitario
Valladolid, Spain, 47003
Sponsors and Collaborators
Red de Terapia Celular
Fundacion Parque Cientifico de la Universidad de Valladolid
Universidad de Valladolid
Instituto de Biologia y Genetica Molecular (IBGM)
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
Results First Received: September 24, 2014
Last Updated: November 4, 2014
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:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on May 29, 2015