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Mesenchymal Stromal Cells for Degenerative Meniscus Injury

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ClinicalTrials.gov Identifier: NCT02033525
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Hospital Universitari Quirón Dexeus
Ministerio de Sanidad, Servicios Sociales e Igualdad
Information provided by (Responsible Party):
Banc de Sang i Teixits

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 10, 2014
Last Update Posted Date January 9, 2018
Actual Study Start Date  ICMJE January 31, 2014
Actual Primary Completion Date May 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
VAS for pain [ Time Frame: 12 month ]
Visual analogue scale (VAS) for pain at 12 month follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02033525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • Safety [ Time Frame: 12 month ]
    Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs.
  • Efficacy by MRI [ Time Frame: 6 and 12 month ]
    Efficacy will be assessed by qualitative and quantitative changes of the meniscus and articular cartilage by imaging procedures (MRI) at 6 and 12 month follow-up.
  • VAS for pain [ Time Frame: 1, 3 and 6 month ]
    Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up.
  • Efficacy by clinical questionnaires [ Time Frame: 3, 6 and 12 month ]
    IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up
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 Mesenchymal Stromal Cells for Degenerative Meniscus Injury
Official Title  ICMJE A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury
Brief Summary The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.
Detailed Description

This is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (Crues et al.) will enter the study with the primary objective of assessing the efficacy of the treatment by VAS of pain at 12 month. Secondary objectives are to evaluate the safety and efficacy through imaging procedures and clinical questionnaires (IKDC, KOOS, Lysholm and SF-36.

Patients will be randomized to one of the two treatment arms (XCEL-M-ALPHA and standard rehabilitation program or standard rehabilitation program alone). Thereafter, patients will be followed for 12 months.

Imaging assessment will be performed by an independent blinded radiologist.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Meniscal Injury
Intervention  ICMJE
  • Drug: XCEL-M-ALPHA and standard rehabilitation
    Intraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank)
    Other Name: XCEL-M-ALPHA
  • Other: Rehabilitation
    Standard rehabilitation program
Study Arms  ICMJE
  • Experimental: XCEL-M-ALPHA and standard rehabilitation
    Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program
    Intervention: Drug: XCEL-M-ALPHA and standard rehabilitation
  • Active Comparator: standard rehabilitation
    Standard rehabilitation program
    Intervention: Other: Rehabilitation
Publications * Not Provided

*   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: January 9, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2, 2017
Actual Primary Completion Date May 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient between 40 and 60 years of age
  • Degenerative meniscus injury grade 3 (Crues et al.)
  • Indication of conservative treatment
  • Normal alignment of the knee (between 3º varus and 10 º valgus)
  • Patient is able to follow a rehabilitation program
  • Informed consent given by the patient in writing
  • Patient is able to understand the trial.

Exclusion Criteria:

  • Traumatic meniscus injury
  • Surgical intervention to the affected knee
  • Local or systemic infection
  • Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
  • Significant abnormal laboratory tests that contraindicates participation in the trial.
  • Pregnant women or intend to become pregnant or breast-feeding
  • Neoplastic process within the previous 5 years or without complete remission.
  • The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
  • Legally dependant patient.
  • The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 60 Years   (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 NCT02033525
Other Study ID Numbers  ICMJE XCEL-MEN-01
2011-006270-13 ( EudraCT Number )
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
  • Hospital Universitari Quirón Dexeus
  • Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators  ICMJE
Principal Investigator: Joan Carles Monllau, MD, PhD ICATME-Hospital Quiron Dexeus
PRS Account Banc de Sang i Teixits
Verification Date January 2018

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