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

Francisco Espinoza, MD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: Hyaluronic Acid; Biological: umbilical-cord mesenchymal stromal cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02580695

C4COA01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Umbilical-cord mesenchymal stromal cells

Experimental group

Description:

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

Treatment:

Biological: umbilical-cord mesenchymal stromal cells

Hyaluronic Acid (HA)

Active Comparator group

Description:

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

Treatment:

Drug: Hyaluronic Acid