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

NCT ID: NCT02580695

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

umbilical-cord mesenchymal stromal cells

Intervention Type BIOLOGICAL

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

Hyaluronic Acid (HA)

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

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type DRUG

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

Interventions

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umbilical-cord mesenchymal stromal cells

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

Intervention Type BIOLOGICAL

Hyaluronic Acid

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

Intervention Type DRUG

Other Intervention Names

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UC-MSCs Durolane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Francisco Espinoza, MD

OTHER

Sponsor Role lead

Responsible Party

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Francisco Espinoza, MD

Alternative Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jose Matas, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Los Andes

Locations

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Clinica Universidad de los Andes

Santiago, , Chile

Site Status

Countries

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Chile

Other Identifiers

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C4COA01

Identifier Type: -

Identifier Source: org_study_id