This trial is active, not recruiting.

Condition osteoarthritis
Treatments umbilical-cord mesenchymal stromal cells, hyaluronic acid
Phase phase 1/phase 2
Sponsor Francisco Espinoza, MD
Start date December 2015
End date January 2017
Trial size 30 participants
Trial identifier NCT02580695, C4COA01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
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
umbilical-cord mesenchymal stromal cells UC-MSCs
Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months
(Active Comparator)
Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months
hyaluronic acid Durolane
Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months

Primary Outcomes

Proportion of patients who experience an adverse event
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
Principal investigator Jose Matas, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Universidad Los Andes, Chile.