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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Chile
Study Type
Interventional
Intervention
umbilical-cord mesenchymal stromal cells
Hyaluronic Acid
Sponsored by
Francisco Espinoza, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica Universidad de los Andes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Umbilical-cord mesenchymal stromal cells

Hyaluronic Acid (HA)

Arm Description

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

Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months

Outcomes

Primary Outcome Measures

Proportion of patients who experience an adverse event
according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)

Secondary Outcome Measures

Physical function improvement measured by WOMAC OA index
Change in pain density measured by Visual analogue scale (VAS)
QoL improvement measured by SF-36
Changes in WORMS scale measured by knee MRI

Full Information

First Posted
October 15, 2015
Last Updated
December 24, 2018
Sponsor
Francisco Espinoza, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02580695
Brief Title
A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Espinoza, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical-cord mesenchymal stromal cells
Arm Type
Experimental
Arm Description
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
Arm Title
Hyaluronic Acid (HA)
Arm Type
Active Comparator
Arm Description
Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months
Intervention Type
Biological
Intervention Name(s)
umbilical-cord mesenchymal stromal cells
Other Intervention Name(s)
UC-MSCs
Intervention Description
Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
Durolane
Intervention Description
Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months
Primary Outcome Measure Information:
Title
Proportion of patients who experience an adverse event
Description
according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Physical function improvement measured by WOMAC OA index
Time Frame
12 months
Title
Change in pain density measured by Visual analogue scale (VAS)
Time Frame
12 months
Title
QoL improvement measured by SF-36
Time Frame
12 months
Title
Changes in WORMS scale measured by knee MRI
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Matas, MD
Organizational Affiliation
Universidad de Los Andes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Universidad de los Andes
City
Santiago
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

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

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