A clinical study to evaluate the effect CYP-002 in adults with Critical Limb Ischemia who are unsuitable for surgery to improve blood circulatio
- Conditions
- Critical Limb IschaemiaMedDRA version: 21.1Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866MedDRA version: 21.1Level: LLTClassification code 10058072Term: Critical limb ischaemiaSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2019-001361-33-GB
- Lead Sponsor
- Cynata Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
Prospective participants must meet all of the following inclusion criteria to be eligible to participate in the study:
1. Provide written informed consent.
2. Male or female, 45 years of age or older.
3. Diagnosed with CLI, Rutherford Category 5.
4. At least one of the following findings in the index leg:
a. ABI of less than 0.5.
b. Ankle pressure of less than 60 mmHg.
c. A measurable toe pressure of less than 40 mmHg.
d. In cases where the ABI is more than 1.4 (indicating false elevation of ABI) and toe pressure is not measurable, inclusion may be based on a TcPO2 reading of less than 30 mmHg.
5. In the opinion of the Investigator revascularisation is not appropriate or has previously failed.
6. Negative urine pregnancy test at screening, if applicable (i.e. for female participants of childbearing potential).
7. Willing to comply with birth control measures (if applicable), to prevent female participants becoming pregnant for six months following administration of the study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81
If prospective participants meet any of the following exclusion criteria, they are ineligible to participate in the study:
1. Pregnant or breastfeeding
2. Planning to become pregnant within six months.
3. Arterial insufficiency in the lower limbs known or suspected to be the result of acute limb ischaemia or an immunological, inflammatory or non-atherosclerotic disorder (e.g. Buerger's Disease, systemic sclerosis).
4. Undergone surgical or endovascular revascularisation of the index leg within 7 days prior to the planned administration of study treatment.
5. Amputation at or above the talus of the index leg.
6. Amputation of the index leg is already planned.
7. BMI > 45 kg/m2.
8. Systolic blood pressure =180 mmHg.
9. Received the SGLT2 inhibitor canagliflozin within 60 days prior to the planned administration of study treatment.
10. Received chemotherapy treatment within 12 months prior to the planned administration of study treatment.
11. Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment.
12. Require improvement of arterial inflow above the aortic bifurcation.
13. Experienced acute myocardial infarction, unstable angina or stroke within three months prior to screening.
14. Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus, Hepatitis C virus or any other infection which the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study.
15. Active malignancy or history of malignancy within five years prior to screening (with the exception of a past history of basal or squamous cell carcinomas).
16. Known or suspected (in the opinion of the Investigator) alcohol or substance abuse problem.
17. Known sensitivity to dimethylsulfoxide (DMSO) or any other component of the study treatments.
18. Life expectancy of less than six months, in the opinion of the Investigator.
19. Any other medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To evaluate the efficacy of CYP-002 in adults with CLI, based on improvement in Rutherford Classification up to 12 months after treatment.<br>- To assess the safety and tolerability of CYP-002 in adults with CLI, up to 12 months after treatment.<br>;Secondary Objective: - To evaluate the efficacy of CYP-002 in adults with CLI, based on different outcome measures at various timepoints up to 24 months after treatment.<br>- To further assess the safety and tolerability of CYP-002 in adults with CLI up to 24 months after treatment.;Primary end point(s): - Improvement in Rutherford Classification from Category 5 to Category 4 or lower, from baseline to 12 months<br><br>• Incidence and severity of TEAEs<br>• Safety laboratory evaluations (biochemistry, haematology, urinalysis)<br>• Vital sign values<br>• Oxygen saturation;Timepoint(s) of evaluation of this end point: Up to 12 months after treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The efficacy of CYP-002 in adults with CLI will be based on the following outcomes measures over time in the index leg:<br>• Improvement in Rutherford Classification from Category 5 to Category 4, or lower*<br>• AFS+<br>• Change in ABI+<br>• Change in ischaemic rest pain as measured by VAS+<br>• Extent of wound healing+<br>• Change in quality of life as measured by VQ-6+.<br>(* Assessed at 6, 18 and 24 months after treatment)<br>(+ Assessed at 6, 12, 18 and 24 months after treatment)<br><br>• Incidence and severity of TEAEs<br>• Safety laboratory evaluations (clinical chemistry, haematology, urinalysis)<br>• Vital signs.;Timepoint(s) of evaluation of this end point: Up to 24 months after treatment