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Completed

NCT Number: NCT02033525

Mesenchymal Stromal Cells for Degenerative 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.

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Key information

Conditions

Chronic Meniscal Injury

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

ICATME-Hospital Quiron Dexeus

Barcelona, 08028, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XCEL-M-ALPHA and standard rehabilitation

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)

Other names: XCEL-M-ALPHA

rehabilitation

Other

Standard rehabilitation program

Primary outcomes

  1. VAS for pain

    Time frame: 12 month

    Visual analogue scale (VAS) for pain at 12 month follow-up.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Banc de Sang i Teixits

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2014
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.