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

Francisco Espinoza, MD30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis

Interventions

umbilical-cord mesenchymal stromal cells

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients who experience an adverse event

according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)

Time frame: 12 months

Secondary Outcomes

Physical function improvement measured by WOMAC OA index

Time frame: 12 months

Change in pain density measured by Visual analogue scale (VAS)

Time frame: 12 months

QoL improvement measured by SF-36

Time frame: 12 months

Changes in WORMS scale measured by knee MRI

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes