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Completed

NCT Number: NCT01227694

Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires.

MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month.

The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Cartilage Diseases Connective Tissue Diseases Joint Diseases Knee Injuries Leg Injuries Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centro Medico Teknon-ITRT

Barcelona, 08022, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
  • Chronic knee pain with mechanical characteristics
  • Absence of local or systemic septic process
  • Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
  • Informed Consent form signed by the patient
  • The patient is able to understand the nature of the study

Exclusion criteria

  • Patients < 18 years or legally dependent
  • Patients >65 years
  • Previous surgery of the knee
  • Intraarticular treatment in the past 6 month
  • Knee ligament or meniscus rupture observed by MRI
  • Any sign of infection
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), 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).
  • Pregnant women 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

Treatment and study plan

Autologous MSC knee implantation

Other

Isolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection.

Other names: Xcel-m-condro-alpha

Primary outcomes

  1. Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.

    Time frame: 12 months

    Feasibility will be assessed by checking the cascade of procedures (from bone marrow extraction to MSC implantation) and confirming the global process is viable.

  2. Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.

    Time frame: 12 months

    Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months.

Secondary outcomes

  1. Efficacy by imaging procedures.

    Time frame: 6 months

    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).

  2. Efficacy by imaging procedures.

    Time frame: 12 month

    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).

  3. Clinical outcomes.

    Time frame: 3 month

    Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36).

  4. Clinical outcomes.

    Time frame: 6 months

    Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36).

  5. Clinical outcomes.

    Time frame: 12 months

    Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36).

Sponsors and collaborators

Lead sponsor

Banc de Sang i Teixits

Other

Collaborators

  • Centro Medico Teknon
  • Cetir Sant Jordi, S.a..
  • Institut de Terapia Regenerativa Tissular

Registry information

Official study title

Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 25, 2010
Registry last updated
Dec 11, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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