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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03007576 |
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Date of registration:
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21/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
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Scientific title:
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Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem) |
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Date of first enrolment:
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August 1, 2017 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03007576 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Taiwan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects who understand and sign the informed consent form for this study
2. Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with
one-month X-ray
3. Age is 50~75 years old
4. Postmenopausal women
5. VAS scores in 50 to 90 mm
Exclusion Criteria:
1. Abnormal of liver and kidney: GOT and GPT > 100 IU/L, BUN >22 mg/dl and creatinine >
1.2 mg/dl.
2. Positive serology for HIV, HTLV-1/2 and syphilis
3. Women who are pregnant or breast feeding
4. Serious pre-existing medical conditions: coagulation disorders, cardiovascular
diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic
renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.
5. Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus
greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis,
serious meniscal tear, other autoimmune arthritis.
6. Skin inflammatory of knee
7. Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain
combined with pain from spine disease or hip disease.
8. Immunosuppressive state
9. Subjects who were injected with hyaluronic acid and PRP in the past 6 months
10. Body mass index (BMI) greater than 30
11. Have a history of allergic reaction of any medication
12. Participation in another clinical trial or treatment within 3 months
13. Other pathologic conditions or circumstances that difficult participation in this
study according to PI's evaluations
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis,Knee
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Intervention(s)
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Biological: RegStem
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Primary Outcome(s)
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Clinical assessment of International Knee Documentation Committee (IKDC) score
[Time Frame: 48 weeks]
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Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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Clinical assessment of visual analogue scale (VAS)
[Time Frame: 48 weeks]
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Clinical assessment of knee MRI
[Time Frame: 48 weeks]
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Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)
[Time Frame: 48 weeks]
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Clinical assessment of knee X-ray
[Time Frame: 48 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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