Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis
NCT ID: NCT03810521
Last Updated: 2019-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2019-03-01
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
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
umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
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
umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
Interventions
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umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
75 Years
ALL
No
Sponsors
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Universidad de los Andes, Chile
OTHER
Responsible Party
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Francisco Espinoza
Associate Professor
Principal Investigators
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Francisco Espinoza, MD
Role: PRINCIPAL_INVESTIGATOR
CMO
Locations
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Clínica Universidad de los Andes
Santiago, XIII, Chile
Countries
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Central Contacts
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Facility Contacts
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References
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Matas J, Garcia C, Poblete D, Vernal R, Ortloff A, Luque-Campos N, Hidalgo Y, Cuenca J, Infante C, Cadiz MI, Khoury M, Luz-Crawford P, Espinoza F. A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis. Stem Cells Transl Med. 2024 Mar 15;13(3):193-203. doi: 10.1093/stcltm/szad088.
Other Identifiers
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CLT-OA1
Identifier Type: -
Identifier Source: org_study_id
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