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| Name | Class |
|---|---|
| KCRI | OTHER |
| National Center for Research and Development, Poland | OTHER |
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The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.
It is planned to enroll 105 patients into N-O CLI trial with randomization into active (CardioCell) therapy and sham procedure/placebo administration with 2:1 ratio.
The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with N-O CLI.
There are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe in each studied indication and way of CardioCell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Active Comparator | Patients randomized to the active treatment group will receive CardioCell consist 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin); 15 000 000 via common femoral artery injection and 15 000 000 via intramuscular injections above the knee (ATK, 6 injection sites) and below the knee (BTK, 6 injection sites). |
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| Control Group | Placebo Comparator | Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) injections in the same manner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioCell | Drug | Patients in the N-O CLI trial will receive a full dose of IMP three times during the trial: at baseline, after 45 days post index administration and after 3 months post index administration. IMP will be administered into femoral artery and intramuscularly with 50:50 proportion. The intramuscularly dose will be administered into muscles above and below the knee in 50:50 proportion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain-free walking distance | Change in pain-free walking distance (6M FU vs index evaluation) between two groups (active vs placebo therapy). | 6 month FU |
| Measure | Description | Time Frame |
|---|---|---|
| Amputation-free survival period | Amputation-free survival period evaluation of treated leg at 6 month and 1 year FU. | 6 month and 1 year FU. |
| Ulcer-free survival | Ulcer-free survival (in patients without ulceration at baseline evaluation) of treated leg in period evaluation at 6 month and 1 year FU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariusz Trystuła, MD | John Paul II Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice | Katowice | 40-635 | Poland | |||
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The N-O CLI trial will enroll 105 patients with randomization into active and sham therapy with 2:1 ratio.
Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early uptake and retention of IMP in the target ischemic tissues.
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The Data and Safety Monitoring Board (DSMB) will be blinded at project start, but may request unblinding if necessary to accommodate effective review of data.
Other than the DSMB (if necessary), the only other "un-blinded parties", meaning that they will have knowledge as to the patient's treatment assignment, will be the PBTiK UJ CM employee who participates in randomization utilizing randomization lists and investigational medication preparation.
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| Placebos | Drug | Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner. Control group will receive the same amount of fluid used for WJMSCs preparation, without cells. |
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| 6 month and 1 year FU |
| Ulcer-extension free survival | Ulcer-extension free survival (in patients with ulceration in the beginning of the trial) of treated leg in period evaluation at 6 month and 1 year FU. | 6 month and 1 year FU |
| Change in tissue oxygen/CO2 tension | Change in tissue oxygen/CO2 tension, assessed by NIRS method at each trial evaluation point. | 45 days, 3 month, 6 month and 1 year FU |
| An improvement of tissue perfusion | An improvement of tissue perfusion assessed in MRI at each trial evaluation point. | 45 days, 3 month, 6 month and 1 year FU |
| Change in transcutaneous pressure of O2 | Change in transcutaneous pressure of O2 (tcpO2) between two groups (active vs placebo therapy) at each trial evaluation point. | 45 days, 3 month, 6 month and 1 year FU |
| Change in ABI score | Change in ABI score at each trial evaluation point. The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm and is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. An ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates peripheral arterial disease. An ABI value of 1.3 or greater is also considered abnormal, and suggests calcification of the walls of the arteries and incompressible vessels. ABI score progression towards the normal range is considered as a better outcome. | 45 days, 3 month, 6 month and 1 year FU |
| Quality of life improvement, assessed by SF-36 questionnaire | Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at each trial evaluation point. | 45 days, 3 month, 6 month and 1 year FU |
| The John Paul II Hospital |
| Krakow |
| 31-202 |
| Poland |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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