Mesenchymal Stromal Cells for Degenerative Meniscus Injury

NCT ID: NCT02033525

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-05-02

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.

Conditions

Chronic Meniscal Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

XCEL-M-ALPHA and standard rehabilitation

Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program

Group Type: EXPERIMENTAL

XCEL-M-ALPHA and standard rehabilitation

Intervention Type: DRUG

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)

standard rehabilitation

Standard rehabilitation program

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: OTHER

Standard rehabilitation program

Interventions

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)

Intervention Type: DRUG

Rehabilitation

Standard rehabilitation program

Intervention Type: OTHER

Other Intervention Names

XCEL-M-ALPHA

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Quirón Dexeus

UNKNOWN

Sponsor Role: collaborator

Ministerio de Sanidad, Servicios Sociales e Igualdad

OTHER_GOV

Sponsor Role: collaborator

Banc de Sang i Teixits

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Carles Monllau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ICATME-Hospital Quiron Dexeus

Locations

ICATME-Hospital Quiron Dexeus

Barcelona, , Spain

Countries

Spain

Related Links

http://www.icatme.com/

Fundación ICATME (Spanish only)

Other Identifiers

2011-006270-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

XCEL-MEN-01

Identifier Type: -

Identifier Source: org_study_id