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OpenTrials
Completed

NCT Number: NCT02580695

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinica Universidad de los Andes

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

umbilical-cord mesenchymal stromal cells

Biological

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

Other names: UC-MSCs

Hyaluronic acid

Drug

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

Other names: Durolane

Primary outcomes

  1. Proportion of patients who experience an adverse event

    Time frame: 12 months

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

Secondary outcomes

  1. Physical function improvement measured by WOMAC OA index

    Time frame: 12 months

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

    Time frame: 12 months

  3. QoL improvement measured by SF-36

    Time frame: 12 months

  4. Changes in WORMS scale measured by knee MRI

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Francisco Espinoza, MD

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2015
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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