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

NCT02580695 | Completed Phase 1 DMC

• 1 other identifier: C4COA01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who experience an adverse event

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

  12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Umbilical-cord mesenchymal stromal cells

EXPERIMENTAL

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

Biological: umbilical-cord mesenchymal stromal cells

Hyaluronic Acid (HA)

ACTIVE COMPARATOR

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

Drug: Hyaluronic Acid

Interventions

umbilical-cord mesenchymal stromal cells BIOLOGICAL

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

Also known as: UC-MSCs

Umbilical-cord mesenchymal stromal cells

Hyaluronic Acid DRUG

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

Also known as: Durolane

Hyaluronic Acid (HA)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Francisco Espinoza, MD: lead

Study Sites (1)

Clinica Universidad de los Andes

Santiago, Chile

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Jose Matas, MD

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Alternative Investigator

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 20, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

CL (1)