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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
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.
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.
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Katowice, Poland
The John Paul II Hospital
Krakow, Poland
Change in pain-free walking distance
Change in pain-free walking distance (6M FU vs index evaluation) between two groups (active vs placebo therapy).
Time frame: 6 month FU
Amputation-free survival period
Amputation-free survival period evaluation of treated leg at 6 month and 1 year FU.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 45 days, 3 month, 6 month and 1 year FU
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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.
Time frame: 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.
Time frame: 45 days, 3 month, 6 month and 1 year FU