Trial intelligence / Profile preview

XCEL-M-ALPHA for Meniscus Injury

NCT02033525Phase 2

Key facts

Status: Completed
Start: Jan 2014
Primary completion: May 2017
Countries: 1
Sponsor: Banc de Sang i Teixits
Modality: Cell Therapies

Drugs: XCEL-M-ALPHA
Conditions: Degenerative Meniscus Tear (DMT)

Overview

Phase 2, randomised, single-blind trial of XCEL-M-ALPHA in Degenerative Meniscus Tear (DMT) (2 arms), sponsored by Banc de Sang i Teixits. Primary endpoint: Visual Analog Scale for Pain at 12 months. Started Jan 2014; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

XCEL-M-ALPHA + Rehab
Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation
Standard Rehab
Standard rehabilitation program alone

Who it enrols

Patients aged 40-60 with degenerative meniscus injury grade 3 indicated for conservative treatment, excluding traumatic injury, prior knee surgery, or recent intraarticular injections.

Endpoints

Primary

Visual Analog Scale for Pain12 months

Secondary

Safety Assessment12 months
Magnetic Resonance Imaging Efficacy12 months
Visual Analog Scale for Pain6 months
International Knee Documentation Committee Subjective Knee Form12 months
Knee Injury and Osteoarthritis Outcome Score12 months
Lysholm Knee Scoring Scale12 months
Short Form 36 Health Survey12 months

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