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

October 22, 2010
January 8, 2014
October 2010
July 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01227694 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis
Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Knee Injuries
  • Joint Diseases
  • Rheumatic Diseases
  • Cartilage Diseases
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
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.
Intervention: Other: Autologous MSC knee implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
January 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01227694
XCEL-M-09-01
No
Banc de Sang i Teixits
Banc de Sang i Teixits
  • Centro Medico Teknon
  • Institut de Terapia Regenerativa Tissular
  • CETIR Sant Jordi, Barcelona, Spain
Principal Investigator: Robert Soler, MD Institut de Teràpia Regenerativa Tissular (ITRT)
Banc de Sang i Teixits
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP