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Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

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ClinicalTrials.gov Identifier: NCT01227694
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : December 11, 2015
Sponsor:
Collaborators:
Centro Medico Teknon
Institut de Terapia Regenerativa Tissular
Cetir Sant Jordi, S.a..
Information provided by (Responsible Party):
Banc de Sang i Teixits

Tracking Information
First Submitted Date  ICMJE October 22, 2010
First Posted Date  ICMJE October 25, 2010
Last Update Posted Date December 11, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01227694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
  • Efficacy by imaging procedures. [ Time Frame: 6 months ]
    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
  • Efficacy by imaging procedures. [ Time Frame: 12 month ]
    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis
Official Title  ICMJE Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Knee Injuries
  • Joint Diseases
  • Rheumatic Diseases
  • Cartilage Diseases
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2010)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01227694
Other Study ID Numbers  ICMJE XCEL-M-09-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Banc de Sang i Teixits
Study Sponsor  ICMJE Banc de Sang i Teixits
Collaborators  ICMJE
  • Centro Medico Teknon
  • Institut de Terapia Regenerativa Tissular
  • Cetir Sant Jordi, S.a..
Investigators  ICMJE
Principal Investigator: Robert Soler, MD Institut de Teràpia Regenerativa Tissular (ITRT)
PRS Account Banc de Sang i Teixits
Verification Date November 2015

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