Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological)
of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients
with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10
patients for each group. The investigators compare the intraarticular injection of hialuronic
acid against the administration of two different doses of mesenchymal stem cells with
hialuronic acid according to the following scheme:
1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous
mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small
volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an
intraarticular injection Hiaurónico Acid ( Hyalone®).
3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous
mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small
volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an
intraarticular injection Hiaurónico Acid (Hyalone®).
The primary endpoint is safety and feasibility. The investigators registered the occurrence
of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM
analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since
treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
- Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the
number location of the lesions , cartilage thickness , signal intensity , subchondral
bone alteration , volume and WORMS and dGEMRIC protocols.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra