Osteoarthritis
Conditions
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.
Interventions
BIOLOGICALumbilical-cord mesenchymal stromal cells
Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months
DRUGHyaluronic Acid
Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months
Sponsors
Francisco Espinoza, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who experience an adverse event | 12 months | according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Chile
Outcome results
None listed