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Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

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ClinicalTrials.gov Identifier: NCT03810521
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Espinoza, Universidad de los Andes, Chile

Study Description
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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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: umbilical cord derived-mesenchymal stromal cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: CLT low-dose
Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
 Biological: umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
Experimental: CLT medium-dose
Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
 Biological: umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
Experimental: CLT high-dose
Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
 Biological: umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in WOMAC score [ Time Frame: 6 months ]
  2. Change in VAS score [ Time Frame: 6 months ]
  3. Changes in structural joint assessment by MRI [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810521


Contacts
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Contact: Francisco Espinoza, MD 56226181008 fespinoza@uandes.cl
Contact: Roberto Bobadilla 56226181000 rbobadilla@c4c.cl

Locations
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Chile
Clínica Universidad de los Andes Recruiting
Santiago, Xiii, Chile, 7620001
Contact: Jose Matas, MD    56226181000    jmatas@uandes.cl   
Contact: Eduardo Carrasco, MD    56226181000    ecarrasco@clinicauandes.cl   
Sponsors and Collaborators
Universidad de los Andes, Chile
Investigators
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Principal Investigator: Francisco Espinoza, MD CMO
More Information
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Responsible Party: Francisco Espinoza, Associate Professor, Universidad de los Andes, Chile
ClinicalTrials.gov Identifier: NCT03810521     History of Changes
Other Study ID Numbers: CLT-OA1
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francisco Espinoza, Universidad de los Andes, Chile:
mesenchymal stromal cells

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases