Mesenchymal Stromal Cells for Degenerative Meniscus Injury

January 8, 2018 updated by: Banc de Sang i Teixits

A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • ICATME-Hospital Quiron Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • XCEL-M-ALPHA
Active Comparator: standard rehabilitation
Standard rehabilitation program
Other: Rehabilitation
Standard rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS for pain
Time Frame: 12 month
Visual analogue scale (VAS) for pain at 12 month follow-up.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 12 month
Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs.
12 month
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.
6 and 12 month
VAS for pain
Time Frame: 1, 3 and 6 month
Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up.
1, 3 and 6 month
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
3, 6 and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banc de Sang i Teixits

Collaborators

Ministerio de Sanidad, Servicios Sociales e Igualdad
Hospital Universitari Quirón Dexeus

Investigators

  • Principal Investigator: Joan Carles Monllau, MD, PhD, ICATME-Hospital Quiron Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2014

Primary Completion (Actual)

May 2, 2017

Study Completion (Actual)

May 2, 2017

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCEL-MEN-01
  • 2011-006270-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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