Clinical trial NCT03423732: Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Critical Limb Ischemia
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
Collaborators: name: KCRI
name: National Center for Research and Development, Poland
First posted: 2018-02-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project

Primary outcomes:
measure: Change in pain-free walking distance
timeFrame: 6 month FU
Secondary outcomes:
measure: Amputation-free survival period
timeFrame: 6 month and 1 year FU.
measure: Ulcer-free survival
timeFrame: 6 month and 1 year FU
measure: Ulcer-extension free survival
timeFrame: 6 month and 1 year FU
measure: Change in tissue oxygen/CO2 tension
timeFrame: 45 days, 3 month, 6 month and 1 year FU
measure: An improvement of tissue perfusion
timeFrame: 45 days, 3 month, 6 month and 1 year FU
measure: Change in transcutaneous pressure of O2
timeFrame: 45 days, 3 month, 6 month and 1 year FU
measure: Change in ABI score
timeFrame: 45 days, 3 month, 6 month and 1 year FU
measure: Quality of life improvement, assessed by SF-36 questionnaire
timeFrame: 45 days, 3 month, 6 month and 1 year FU
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: The John Paul II Hospital
city: Katowice
country: Poland
facility: Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Study officials:
affiliation: John Paul II Hospital
name: Mariusz Trystuła, MD
role: PRINCIPAL_INVESTIGATOR
References: