Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT03455335
Eligibility Criteria:
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled into the study
1. Men and women between the ages of 18 and 85
2. Voluntary written informed consent, given before performance of any study-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care
3. Presented with CLI with rest pain or ulceration with no option for revascularization agreed by an expert panel including an interventional radiologist and vascular surgeon; CLI defined as persistent ischemic rest pain for greater than or equal to 2 weeks and/or ulceration or gangrene of the toe or foot
4. Estimated life expectancy \> 6 months as deemed by patient's clinician and/or investigator
5. Suitable candidate for a bone marrow aspiration, deemed by Consultant Haematologist
6. Chronic critical limb ischaemia with rest pain (Rutherford Class 4) or mild-to-moderate tissue loss (Rutherford Class 5) who are not candidates for revascularisation
7. Medically fit to undergo bone marrow harvest and stem cell intramuscular injection
8. One of the following haemodynamic parameters: ankle systolic pressure \< 70 mmHg or ABI \<0.9 TBI \<0 .6 TcPO2 \<60mmHg on room air
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
1. Has received prior therapy with MSCs
2. Has had previous amputation of the talus or above
3. Has failed revascularization within 2 weeks before entry to the study
4. Known Aortoiliac disease with \> 50% stenosis
5. Contraindication to intramuscular procedure, including active infection in the affected limb, or wet gangrene or exposed bone or tendon in lower limb with CLI, or in the opinion of the attending clinician, is unsuitable for intramuscular procedure
6. Severe co-morbidity limiting 6 month survival of patients
7. Abnormal liver function as defined by AST and ALT \> 2.5 fold the ULN and total bilirubin \> 1.5 ULN
8. Significant cognitive impairment (Mini Mental Status Examination \<22)
9. Presence of proliferative retinopathy (in participants with diabetes mellitus only)
10. Presence of poorly controlled diabetes mellitus with HbAIc \> 10% within previous 3 months
11. HIV or HBsAg positive
12. Presence of acute coronary syndrome
13. Patient has known active malignancy
14. Pregnancy
15. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
16. Patient taking other investigational drugs at the time of enrolment or within 28 days of enrolment
17. Rutherford class 6 CLI
18. Significant bone marrow dysfunction, based on assessment by Haematologist or an established diagnosis of myelodysplasia, or myeloproliferative disorder etc.
19. Bleeding diathesis, coagulopathy, thrombocytopenia etc.
20. Patients in whom delay incurred by attempts at limb salvage using MSCs will adversely affect prognosis in the opinion of the responsible attending clinician
21. Patients with known allergy to foetal bovine serum or trypsin
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03455335
Study Brief:
Protocol Section:
NCT03455335