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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Francisco Espinoza, MD
• Treatments: Hyaluronic Acid

Criteria

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