|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02237846 |
|
Date of registration:
|
09/09/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
|
|
Scientific title:
|
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis |
|
Date of first enrolment:
|
September 2014 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT02237846 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Panama
| | | | | | | |
|
Contacts
|
|
Name:
|
Salomon Dayan, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Signed informed consent by the subject.
- Age greater than or equal to 18 years
- Ability to understand the planned treatment.
- Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic
severity, as defined by the modified Kellgren-Lawrence classification
Exclusion Criteria:
- Pregnant or lactating women
- Women of childbearing potential unwilling to use two forms of contraception
- Cognitively impaired adults.
- Presence of large meniscal tears ("bucket handle" tears), as detected by clinical
examination or by magnetic resonance imaging.
- Inflammatory or postinfectious arthritis.
- More than 5 degrees of varus or valgus deformity.
- Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral
compartments of the tibiofemoral joint or the patellofemoral compartment) in persons
over 60 years of age.
- Intraarticular corticosteroid injection within the previous 3 months.
- A major neurologic deficit.
- Serious medical illness with a life expectancy of less than 1 year.
- Prior admission for substance abuse
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study
within 30 days of signing the informed consent
- In the opinion of the investigator or the sponsor the patient is unsuitable for
cellular therapy
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Osteoarthritis of the Knee
|
|
Intervention(s)
|
|
Biological: Human umbilical cord tissue-derived mesenchymal stem cells
|
|
Primary Outcome(s)
|
|
Number of participants with adverse events
[Time Frame: 3 months and 12 months]
|
|
Secondary Outcome(s)
|
|
Number of participants with a change in joint function from baseline WOMAC assessment
[Time Frame: 3 months and 12 months]
|
|
Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system
[Time Frame: 3 months and 12 months]
|
|
Secondary ID(s)
|
|
CNEI-2014-TBS-UCMSCOA-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|