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Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

This study has been completed.
Sponsor:
Collaborators:
Centro Medico Teknon
Institut de Terapia Regenerativa Tissular
CETIR Sant Jordi, Barcelona, Spain
Information provided by (Responsible Party):
Banc de Sang i Teixits
ClinicalTrials.gov Identifier:
NCT01227694
First received: October 22, 2010
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Knee Injuries
Joint Diseases
Rheumatic Diseases
Cartilage Diseases
Other: Autologous MSC knee implantation
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: Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.

Resource links provided by NLM:


Further study details as provided by Banc de Sang i Teixits:

Primary Outcome Measures:
  • Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Feasibility will be assessed by checking the cascade of procedures (from bone marrow extraction to MSC implantation) and confirming the global process is viable.

  • Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months.


Secondary Outcome Measures:
  • Efficacy by imaging procedures. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).

  • Efficacy by imaging procedures. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).

  • Clinical outcomes. [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
    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).

  • Clinical outcomes. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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).

  • Clinical outcomes. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 15
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous MSC knee implantation
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: Autologous MSC knee implantation
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 Name: Xcel-m-condro-alpha

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients < 18 years or legally dependent
  2. Patients >65 years
  3. Previous surgery of the knee
  4. Intraarticular treatment in the past 6 month
  5. Knee ligament or meniscus rupture observed by MRI
  6. Any sign of infection
  7. Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
  8. Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
  9. Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
  10. Pregnant women or intend to become pregnant or breast-feeding
  11. Neoplasia
  12. Immunosuppressive states
  13. Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
  14. 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: NCT01227694

Locations
Spain
Centro Medico Teknon-ITRT
Barcelona, Spain, 08022
Sponsors and Collaborators
Banc de Sang i Teixits
Centro Medico Teknon
Institut de Terapia Regenerativa Tissular
CETIR Sant Jordi, Barcelona, Spain
Investigators
Principal Investigator: Robert Soler, MD Institut de Teràpia Regenerativa Tissular (ITRT)
  More Information

Additional Information:
No publications provided

Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT01227694     History of Changes
Other Study ID Numbers: XCEL-M-09-01
Study First Received: October 22, 2010
Last Updated: January 8, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Banc de Sang i Teixits:
Cell therapy
Regenerative therapy
Advance therapy
Bone marrow
Mesenchymal stem cell
Autologous
Interventional clinical trial
Osteoarthrosis
Osteoarthritis
Knee

Additional relevant MeSH terms:
Cartilage Diseases
Joint Diseases
Knee Injuries
Osteoarthritis
Osteoarthritis, Knee
Rheumatic Diseases
Arthritis
Connective Tissue Diseases
Leg Injuries
Musculoskeletal Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014