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

NCT03423732 | Unknown Phase 2 DMC

• 1 other identifier: CardioCell in N-O CLI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Change in pain-free walking distance

  Change in pain-free walking distance (6M FU vs index evaluation) between two groups (active vs placebo therapy).

  6 month FU

Secondary Outcomes (8)

• 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

Study Arms (2)

Active Group

ACTIVE COMPARATOR

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).

Drug: CardioCell

Control Group

PLACEBO COMPARATOR

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.

Drug: Placebos

Interventions

CardioCell DRUG

Patients in the N-O CLI trial will receive a full dose of IMP three times during the trial: at baseline, after 45 days post index administration and after 3 months post index administration. IMP will be administered into femoral artery and intramuscularly with 50:50 proportion. The intramuscularly dose will be administered into muscles above and below the knee in 50:50 proportion.

Also known as: CardioCell administration

Active Group

Placebos DRUG

Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner. Control group will receive the same amount of fluid used for WJMSCs preparation, without cells.

Also known as: Placebo administration

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead
• KCRI: collaborator
• National Center for Research and Development, Poland: collaborator

Study Sites (2)

Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice

Katowice, 40-635, Poland

Location

The John Paul II Hospital

Krakow, 31-202, Poland

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Mariusz Trystuła, MD

  John Paul II Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Data and Safety Monitoring Board (DSMB) will be blinded at project start, but may request unblinding if necessary to accommodate effective review of data. Other than the DSMB (if necessary), the only other "un-blinded parties", meaning that they will have knowledge as to the patient's treatment assignment, will be the PBTiK UJ CM employee who participates in randomization utilizing randomization lists and investigational medication preparation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 6, 2018
• Study Start: April 19, 2018
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

PL (2)