Critical Limb IschemiaPhase 2/3NCT03423732
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)
A Phase 2/3 study testing CardioCell in people with Critical Limb Ischemia, run by John Paul II Hospital, Krakow at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- CardioCell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesPoland
- Study dates
- 19 Apr 2018to 30 Sep 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
Poland2 sites
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Katowice, 40-635
The John Paul II Hospital
Krakow, 31-202
About this study
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)
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.
Read the 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.
- Conditions
- Critical Limb Ischemia
- Being tested
- CardioCell, Placebos
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioCellDrug
Also called CardioCell administration
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.
PlacebosDrug
Also called Placebo administration
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain-free walking distance
Change in pain-free walking distance (6M FU vs index evaluation) between two groups (active vs placebo therapy).
Measured: 6 month FU
Secondary outcomes (8)
Amputation-free survival period
Amputation-free survival period evaluation of treated leg at 6 month and 1 year FU.
Measured: 6 month and 1 year FU.
Ulcer-free survival
Ulcer-free survival (in patients without ulceration at baseline evaluation) of treated leg in period evaluation at 6 month and 1 year FU.
Measured: 6 month and 1 year FU
Ulcer-extension free survival
Ulcer-extension free survival (in patients with ulceration in the beginning of the trial) of treated leg in period evaluation at 6 month and 1 year FU.
Measured: 6 month and 1 year FU
Change in tissue oxygen/CO2 tension
Change in tissue oxygen/CO2 tension, assessed by NIRS method at each trial evaluation point.
Measured: 45 days, 3 month, 6 month and 1 year FU
An improvement of tissue perfusion
An improvement of tissue perfusion assessed in MRI at each trial evaluation point.
Measured: 45 days, 3 month, 6 month and 1 year FU
Change in transcutaneous pressure of O2
Change in transcutaneous pressure of O2 (tcpO2) between two groups (active vs placebo therapy) at each trial evaluation point.
Measured: 45 days, 3 month, 6 month and 1 year FU
Change in ABI score
Change in ABI score at each trial evaluation point.
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm and is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm.
An ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates peripheral arterial disease. An ABI value of 1.3 or greater is also considered abnormal, and suggests calcification of the walls of the arteries and incompressible vessels. ABI score progression towards the normal range is considered as a better outcome.
Measured: 45 days, 3 month, 6 month and 1 year FU
Quality of life improvement, assessed by SF-36 questionnaire
Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at each trial evaluation point.
Measured: 45 days, 3 month, 6 month and 1 year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start19 Apr 2018
- Primary completion31 May 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI, National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Mariusz Trystuła, MD, Principal investigator, John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423732
- Sponsor's protocol ID
- CardioCell in N-O CLI
- Status last verified
- Apr 2021
- First submitted
- 25 Jan 2018
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03423732
- Acronym / sponsor ID
- CardioCell in N-O CLI
- Conditions
- Critical Limb Ischemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Collaborators
- KCRI, National Center for Research and Development, Poland
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Drug: CardioCellPatients 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). |
| Control Group | Placebo comparator | Drug: PlacebosPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioCellAlso: CardioCell administrationPatients 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. | Drug | Active Group |
| PlacebosAlso: Placebo administrationPatients 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. | Drug | Control Group |
Primary outcome
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).
8 secondary outcomes
Amputation-free survival period
Time frame: 6 month and 1 year FU.
Ulcer-free survival
Time frame: 6 month and 1 year FU
Ulcer-extension free survival
Time frame: 6 month and 1 year FU
Change in tissue oxygen/CO2 tension
Time frame: 45 days, 3 month, 6 month and 1 year FU
An improvement of tissue perfusion
Time frame: 45 days, 3 month, 6 month and 1 year FU
Change in transcutaneous pressure of O2
Time frame: 45 days, 3 month, 6 month and 1 year FU
Change in ABI score
Time frame: 45 days, 3 month, 6 month and 1 year FU
Quality of life improvement, assessed by SF-36 questionnaire
Time frame: 45 days, 3 month, 6 month and 1 year FU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariusz Trystuła, MD principal investigator
John Paul II Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CardioCell in people with Critical Limb Ischemia, run by John Paul II Hospital, Krakow at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain-free walking distance (time frame: 6 month FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.