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Clinical Trials/NCT03810521
NCT03810521
Unknown
Phase 1

A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

Universidad de los Andes, Chile1 site in 1 country24 target enrollmentMarch 1, 2019
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ConditionsOsteoarthritis, Knee

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Universidad de los Andes, Chile
Enrollment
24
Locations
1
Primary Endpoint
Incidence of adverse events
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
December 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Francisco Espinoza

Associate Professor

Universidad de los Andes, Chile

Eligibility Criteria

Inclusion Criteria

  • •Patient between 30 and 75 years old
  • •Knee-OA Kellgren Lawrence grade I to III
  • •Pain density according to visual analogue scale superior or equal to 50 mm
  • •Patelar condromalacia grade I to III
  • •Stable joint with normal physical exploration

Exclusion Criteria

  • •Bilateral symptomatic disease
  • •Local or systemic infection
  • •Neoplasia
  • •Immunosuppression state
  • •Pregnancy
  • •Anticoagulant therapy
  • •Other types of arthritis
  • •Symptomatic disease of hip and/or spine
  • •Intra-articular infiltration with steroids in the last 3 months
  • •Intra-articular infiltration with hyaluronic acid in the last 12 months

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: 6 months

Secondary Outcomes

  • Change in WOMAC score(6 months)
  • Change in VAS score(6 months)
  • Changes in structural joint assessment by MRI(6 months)

Study Sites (1)

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