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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: umbilical-cord mesenchymal stromal cells; Drug: Hyaluronic Acid

• Registration Number: NCT02580695
• Lead Sponsor: Francisco Espinoza, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Study Start: 2015-12
• Primary Completion: 2017-01
• Study Completion: 2017-04
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-24
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical-cord mesenchymal stromal cells	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
Hyaluronic Acid (HA)	Hyaluronic Acid	Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months

Primary Outcome Measures

Name	Time	Method
Proportion of patients who experience an adverse event	12 months	according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinica Universidad de los Andes; 🇨🇱 Santiago, Chile