drugset / Trial / NCT02580695

A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis

NCT02580695

Phase 1/2 Completed 30 enrolled Francisco Espinoza, MD
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.

Timeline

Start
2015-12
Primary completion
2017-01
Completion
2017-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hyaluronic Acid Other / unclassified 3 ml Other
Subject mesenchymal stem cells Cell therapy 2e+07 cells Other

Indications