Status:
UNKNOWN
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)
Lead Sponsor:
John Paul II Hospital, Krakow
Collaborating Sponsors:
KCRI
National Center for Research and Development, Poland
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Patients able to walk
- Male and female patients, aged 18-80 years
- No-option CLI (definition: exhausted revascularization options including surgery or endovascular treatment) in Rutherford stage 4-5
- In case of bilateral N-O CLI, the limb with shorter claudication distance will be treated
- Presence of adequate inflow (patent iliac and common femoral arteries)
- Run-off through at least one (even partially seen) below-the-knee (BTK) artery
- Signed informed consent
Exclusion
- Malignancy
- Moderate or severe immunodeficiency
- Acute or chronic bacterial or viral infectious disease
- Soft tissue disease or local infection in a place of required artery puncture
- Pregnancy or breastfeeding
- Any objective or subjective reason for inability to attend follow-up visits
- Females of childbearing potential, who does not want to use a highly effective method of contraception
- Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
- Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
- Life expectancy \< 1 year
- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03423732
Start Date
April 19 2018
End Date
September 30 2021
Last Update
April 9 2021
Active Locations (2)
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1
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Katowice, Poland, 40-635
2
The John Paul II Hospital
Krakow, Poland, 31-202