Status:
COMPLETED
Autologous Stem Cells for the Treatment of No Option Critical Limb Ischemia
Lead Sponsor:
National University of Ireland, Galway, Ireland
Collaborating Sponsors:
University Hospital of Limerick
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of autologous bone marrow-derived MSCs. Following informed consent, patients who meet the criteria will be scree...
Detailed Description
This is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study to examine the safety of intramuscular autologous transplantation of escalating doses of mesenchymal stem cells to pa...
Eligibility Criteria
Inclusion
- Each patient must meet all of the following inclusion criteria to be enrolled into the study
- Men and women between the ages of 18 and 85
- 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of any study-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care
- 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
- Estimated life expectancy \> 6 months as deemed by patient's clinician and/or investigator
- Suitable candidate for a bone marrow aspiration, deemed by Consultant Haematologist
- 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
- Medically fit to undergo bone marrow harvest and stem cell intramuscular injection
- One of the following haemodynamic parameters: ankle systolic pressure \< 70 mmHg or ABI \<0.9 TBI \<0 .6 TcPO2 \<60mmHg on room air
Exclusion
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Has received prior therapy with MSCs
- Has had previous amputation of the talus or above
- Has failed revascularization within 2 weeks before entry to the study
- Known Aortoiliac disease with \> 50% stenosis
- 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
- Severe co-morbidity limiting 6 month survival of patients
- Abnormal liver function as defined by AST and ALT \> 2.5 fold the ULN and total bilirubin \> 1.5 ULN
- Significant cognitive impairment (Mini Mental Status Examination \<22)
- Presence of proliferative retinopathy (in participants with diabetes mellitus only)
- Presence of poorly controlled diabetes mellitus with HbAIc \> 10% within previous 3 months
- HIV or HBsAg positive
- Presence of acute coronary syndrome
- Patient has known active malignancy
- Pregnancy
- Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
- Patient taking other investigational drugs at the time of enrolment or within 28 days of enrolment
- Rutherford class 6 CLI
- Significant bone marrow dysfunction, based on assessment by Haematologist or an established diagnosis of myelodysplasia, or myeloproliferative disorder etc.
- Bleeding diathesis, coagulopathy, thrombocytopenia etc.
- Patients in whom delay incurred by attempts at limb salvage using MSCs will adversely affect prognosis in the opinion of the responsible attending clinician
- Patients with known allergy to foetal bovine serum or trypsin
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Key Trial Info
Start Date :
March 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03455335
Start Date
March 23 2015
End Date
October 31 2019
Last Update
March 4 2021
Active Locations (1)
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1
Galway University Hospital
Galway, Galway, Ireland, 0