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

F

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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