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

December 24, 2018 updated by: Francisco Espinoza, MD

A Phase I/II, Randomized, Double-blind, Controlled Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in Patients With Knee Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Clinica Universidad de Los Andes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic Knee OA, Kellgren and Lawrence grade I, II, III on plain Rx films.
  • Chondromalacia patella grade I-III on knee MRI. With or without meniscal tear.
  • Stable knee and normal clinical exam of involved extremity
  • Written informed consent for patients.

Exclusion Criteria:

  • Bilateral symptomatic knee OA
  • Local or systemic infection.
  • Active neoplasia or immunosuppressive state
  • Pregnancy or Breastfeeding
  • Body Mass Index ≥ 30
  • Presence of Pacemaker or Lower extremity metal implant
  • Anticoagulant treatment other than aspirin.
  • Recent use of oral (previous month) or intra-articular (previous 3 months) corticosteroids
  • Concomitant inflammatory joint disease (cristal, connective tissue disease)
  • Valgus (>10o) or Varus (>5o) deformity of involved extremity
  • Condilar or Tibial plateau Generalized Bone Marrow edema on MRI
  • Significant symptomatic hip or spine disease
  • Significant abnormality in baseline lab tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Umbilical-cord mesenchymal stromal cells

Umbilical-cord mesenchymal stromal cells (UC-MSCs)

Allogeneic UC-MSCs 20 x 10e6 diluted on 3 mL of saline solution + 5% of Plasma AB

Arm 2a: single infusion group. UC-MSCs at 0 month

Arm 2b: double infusion group. UC-MSCs at 0 and 6 months
Biological: umbilical-cord mesenchymal stromal cells
Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months
Other Names:
  • UC-MSCs
ACTIVE_COMPARATOR: Hyaluronic Acid (HA)
Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months
Drug: Hyaluronic Acid
Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months
Other Names:
  • Durolane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who experience an adverse event
Time Frame: 12 months
according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical function improvement measured by WOMAC OA index
Time Frame: 12 months
12 months
Change in pain density measured by Visual analogue scale (VAS)
Time Frame: 12 months
12 months
QoL improvement measured by SF-36
Time Frame: 12 months
12 months
Changes in WORMS scale measured by knee MRI
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Espinoza, MD

Investigators

  • Principal Investigator: Jose Matas, MD, Universidad de Los Andes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (ESTIMATE)

October 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 24, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4COA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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