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

John Paul II Hospital, Krakow

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Critical Limb Ischemia

Treatments: Drug: CardioCell; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03423732

CardioCell in N-O CLI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Active Group

Active Comparator group

Description:

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).

Treatment:

Drug: CardioCell

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos