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Mesenchymal Stromal Cells for Degenerative Meniscus Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Meniscal Injury Drug: XCEL-M-ALPHA and standard rehabilitation Other: Rehabilitation Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury
Actual Study Start Date : January 31, 2014
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: XCEL-M-ALPHA and standard rehabilitation
Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program
 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
Active Comparator: standard rehabilitation
Standard rehabilitation program
 Other: Rehabilitation
Standard rehabilitation program


Outcome Measures
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Primary Outcome Measures :
  1. VAS for pain [ Time Frame: 12 month ]
    Visual analogue scale (VAS) for pain at 12 month follow-up.


Secondary Outcome Measures :
  1. Safety [ Time Frame: 12 month ]
    Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs.

  2. 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.

  3. VAS for pain [ Time Frame: 1, 3 and 6 month ]
    Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up.

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033525


Locations
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Spain
ICATME-Hospital Quiron Dexeus
Barcelona, Spain, 08028
Sponsors and Collaborators
Banc de Sang i Teixits
Hospital Universitari Quirón Dexeus
Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators
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Principal Investigator: Joan Carles Monllau, MD, PhD ICATME-Hospital Quiron Dexeus
More Information
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Additional Information:
Blood and tissue bank of Catalonia  This link exits the ClinicalTrials.gov site Fundación ICATME (Spanish only)  This link exits the ClinicalTrials.gov site

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Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT02033525    
Other Study ID Numbers: XCEL-MEN-01
2011-006270-13 ( EudraCT Number )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by Banc de Sang i Teixits:
Chronic Meniscal Injury
Degenerative meniscus
Meniscus injury
Meniscal injury
 Mesenchymal stromal cells
Mesenchymal stem cells
Advanced Therapy
Bone marrow
Additional relevant MeSH terms:
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Wounds and Injuries