Status:
UNKNOWN
Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients
Lead Sponsor:
Bundang CHA Hospital
Collaborating Sponsors:
Korea Evaluation Institute of Industrial Technology
Conditions:
Stroke
Umbilical Cord Blood
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial is a clinical trial for the evaluation of the safety and efficacy of umbilical cord blood (UCB) therapy, UCB and erythropoietin (EPO) combination therapy in adult stroke patients.
Detailed Description
UCB is a high-quality source of mesenchymal stem cells, and studies are being actively developed for stroke patients. UCB therapy has a neuroprotective effect through anti-inflammatory effect and anti...
Eligibility Criteria
Inclusion
- Adult patients over 20 years old
- Patients with a stroke lasting from 30 days to less than 9 months
- After hearing and fully understanding the details of this clinical trial, the person or legal representative has agreed to voluntary participation and has agreed in writing to comply with the notice
Exclusion
- Patients with one or more of the following can not participate in the study.
- Patients with uncontrolled hypertension
- A person who has impaired ability of consent, who is not accompanied by a guardian
- Women who are pregnant, lactating, have a pregnancy plan during the trial, or those who do not use an available contraceptive method (women of childbearing age must be negative in the pregnancy test on baseline visit (0 weeks) .)
- Those who satisfy the following conditions
- A person whose ALT / AST is measured at 120 IU / L or more
- Serum creatinine greater than 1.8 mg / dL
- Total bilirubin\> 1.8 mg / dL
- Total WBC count less than 3000 / mm3
- Those with a Hb of 16 g / dL or more
- Platelet count less than 150,000 / uL or more than 675,000 / uL
- Clinically significant infections during the screening period (pneumonia, pyelonephritis, sepsis, etc.)
- Persons with severe medical conditions such as cardiovascular, digestive, respiratory, and endocrine conditions.
- Any kind of confirmed congenital or acquired immune deficiency syndrome
- Those who have been diagnosed with malignant carcinoma (excluding complete remission for more than 10 years)
- If participants have side effects on your medication \[Regarding erythropoietin agent\]
- Patients with hypersensitivity to erythropoietin
- Patients sensitive to mammalian cell-derived drugs or human albumin
- epileptic patients
- Patients with a history of seizures
- Patients on a thrombolytic drug (meaning thrombolytic agent such as Tissue Plasminogen Activator, allowing anti-platelet agents such as aspirin and plavix) \[Related to tacrolimus\] Patients with hypersensitivity to tacrolimus or macrolide compounds
- Patients receiving cyclosporine or bosentan
- Patients receiving potassium-preserving diuretics
- Other If the investigator determines that participation in this trial is not appropriate
Key Trial Info
Start Date :
May 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04013646
Start Date
May 2 2019
End Date
November 2 2021
Last Update
November 5 2020
Active Locations (1)
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1
Bundang CHA Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496