- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810521
Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
January 17, 2019 updated by: Francisco Espinoza, Universidad de los Andes, Chile
A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francisco Espinoza, MD
- Phone Number: 56226181008
- Email: fespinoza@uandes.cl
Study Contact Backup
- Name: Roberto Bobadilla
- Phone Number: 56226181000
- Email: rbobadilla@c4c.cl
Study Locations
-
-
Xiii
-
Santiago, Xiii, Chile, 7620001
- Recruiting
- Clinica Universidad de Los Andes
-
Contact:
- Jose Matas, MD
- Phone Number: 56226181000
- Email: jmatas@uandes.cl
-
Contact:
- Eduardo Carrasco, MD
- Phone Number: 56226181000
- Email: ecarrasco@clinicauandes.cl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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
|
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
|
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in WOMAC score
Time Frame: 6 months
|
6 months
|
Change in VAS score
Time Frame: 6 months
|
6 months
|
Changes in structural joint assessment by MRI
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francisco Espinoza, MD, CMO
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2019
Primary Completion (Anticipated)
October 30, 2019
Study Completion (Anticipated)
December 30, 2019
Study Registration Dates
First Submitted
January 17, 2019
First Submitted That Met QC Criteria
January 17, 2019
First Posted (Actual)
January 18, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2019
Last Update Submitted That Met QC Criteria
January 17, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLT-OA1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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