Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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 treated by the administration of placebo during the sham procedure.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Paul II Hospital, Krakow
• Collaborators: KCRI; National Center for Research and Development, Poland

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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