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NCT Number: NCT01586312

Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Arthritis of Knee Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centro Medico Teknon, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogenic mesenchymal stromal cells injection

Other

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

Hyaluronic acid

Drug

Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)

Other names: Hyaluronic acid, durolane, CE mark:516407

Primary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to one year

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

Secondary outcomes

  1. Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)

    Time frame: up to one year

    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.

  2. Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)

    Time frame: up to one year

    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.

Sponsors and collaborators

Lead sponsor

Red de Terapia Celular

Industry

Collaborators

  • Centro Medico Teknon
  • Sanidad de Castilla y León
  • University of Valladolid

Registry information

Official study title

Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid

Acronym: MSV_allo

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 26, 2012
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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