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

NCT02580695 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-12-26

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

umbilical-cord mesenchymal stromal cells

Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months

DRUG

Hyaluronic Acid

Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months

Sponsors & Collaborators

  • Francisco Espinoza, MD

    lead OTHER

Principal Investigators

  • Jose Matas, MD · Universidad de Los Andes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-01-31
Completion
2017-04-30

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02580695 on ClinicalTrials.gov