Clinical trial using intraarticular administration of stem cells in meniscus injury

• Conditions: Degenerative meniscal lesion; MedDRA version: 15.0Level: PTClassification code 10069364Term: Meniscal degenerationSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-006270-13-ES
• Lead Sponsor: Banc de Sang i Teixits

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patient between 40 and 60 years of age
2. Degenerative meniscus infjury grade 3 (Crues et al.)
3. Indication of conservative treatment
4. Normal alignment of the knee (between 3º varus and 10 º valgus)
5.Patient is able to follow a rehabilitation program
6. Informed consent given by the patient in writing
7. Patient is able to understant the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Traumatic meniscus injury
2. Surgical intervention to the affected knee
3. Local or systemic infection
4. Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
5. Significant abnormal laboratory tests that contraindicates participation in the trial.
6. Pregnant women or intend to become pregnant or breast-feeding
7. The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
8. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
9. The patient does not accept to be followed-up for a period that could exceed the clinical trial length

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified