Mesenchymal Stromal Cells for Degenerative Meniscus Injury

Banc de Sang i Teixits

Status and phase

Completed

Phase 2

Phase 1

Conditions

Chronic Meniscal Injury

Treatments

Drug: XCEL-M-ALPHA and standard rehabilitation

Other: Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT02033525

2011-006270-13 (EudraCT Number)

XCEL-MEN-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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