Regeneration of Ischemic Damages in Cardiovascular System Using Wharton's Jelly as an Unlimited Source of Mesenchymal Stem Cells for Regenerative Medicine. Project of the National Centre for Research and Development (Poland) 'STRATEGMED II'. Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)
Overview
- Phase
- Phase 2
- Intervention
- CardioCell
- Conditions
- Critical Limb Ischemia
- Sponsor
- John Paul II Hospital, Krakow
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in pain-free walking distance
- Last Updated
- 5 years ago
Overview
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 treated by the administration of placebo during the sham procedure.
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 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.
Investigators
Eligibility 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
Arms & Interventions
Active Group
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).
Intervention: CardioCell
Control Group
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.
Intervention: Placebos
Outcomes
Primary Outcomes
Change in pain-free walking distance
Time Frame: 6 month FU
Change in pain-free walking distance (6M FU vs index evaluation) between two groups (active vs placebo therapy).
Secondary Outcomes
- Change in transcutaneous pressure of O2(45 days, 3 month, 6 month and 1 year FU)
- Amputation-free survival period(6 month and 1 year FU.)
- Ulcer-free survival(6 month and 1 year FU)
- Ulcer-extension free survival(6 month and 1 year FU)
- Change in tissue oxygen/CO2 tension(45 days, 3 month, 6 month and 1 year FU)
- An improvement of tissue perfusion(45 days, 3 month, 6 month and 1 year FU)
- Change in ABI score(45 days, 3 month, 6 month and 1 year FU)
- Quality of life improvement, assessed by SF-36 questionnaire(45 days, 3 month, 6 month and 1 year FU)