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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580695
• Other study ID #: C4COA01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: April 2017

Study information

• Verified date: December 2018
• Source: Universidad de los Andes, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• umbilical-cord mesenchymal stromal cells
Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months

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

Locations

Country	Name	City	State
Chile	Clinica Universidad de los Andes	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Francisco Espinoza, MD

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who experience an adverse event	according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)	12 months
Secondary	Physical function improvement measured by WOMAC OA index		12 months
Secondary	Change in pain density measured by Visual analogue scale (VAS)		12 months
Secondary	QoL improvement measured by SF-36		12 months
Secondary	Changes in WORMS scale measured by knee MRI		12 months