Safety Trial Of CTX Cells In Patients With Lower Limb Ischaemia

Launched by RENEURON LIMITED · Aug 2, 2013

Keywords

ClinConnect Summary

Design: The trial is a multi-centre open label, non-comparative, ascending dose safety study, using CTX cells to treat patients with lower limb ischaemia, with follow-up over 12 months.

Pre-treatment selection of patients: Men and women, aged \>50 years with peripheral arterial occlusive disease (Fontaine Stage II through IV) of one leg or both, unsuitable for surgical re-vascularisation, an ankle/brachial pressure index (ABPI) of \<0.9 or a toe/brachial index of \<0.7. Women must be surgically sterile or more than 2 years past their last menstrual period and test negative for pregnancy.

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed and dated written informed consent obtained from the patient.
• • Peripheral arterial occlusive disease due to atherosclerosis (Fontaine stages II, III or IV) of one leg or both defined as
• • Fontaine stage II: Intermittent claudication
• • Fontaine stage III: Rest pain
• • Fontaine stage IV: Ischaemic ulcer or (dry) gangrene
• • Patients unsuitable for surgical re-vascularisation
• • An ABPI of \<0.9 or a toe/brachial index of \<0.7
• • Age \>50 years
• • Males or Females. Women must be surgically sterile or more than 2 years post their last menstrual period and with a negative pregnancy test.
• • Smoker or non-smoker
• • Diabetics and non-diabetics provided HbA1c \<8% (or 64 mmol/mol)
• Exclusion Criteria:
• • Estimated survival of less than 6 months.
• • Infection of the involved extremity manifested by fever, purulence, or severe cellulitis or active wet gangrenous tissue wound with exposed tendon or bone.
• • Failed ipsilateral revascularisation procedure within 8 weeks prior to enrolment (defined as failure to restore adequate circulation, i.e., the procedure did not achieve an increase in ABPI of 0.15 or more, substantial improvement in Pulse Volume Recording, or clinical improvement).
• • Previous amputation of the talus or above in the target limb.
• • Planned major amputation within one month of planned date for injection of study medication (CTX DP).
• • Anticoagulants including heparin, warfarin or analogues within the past month unless these can be discontinued per protocol for seven days prior to injection and two days post injection in the case of warfarin or one day prior to injection and two days post injection in the case of heparin or other anticoagulants.
• • A history of deep vein thrombosis in either leg.
• • Previous treatment with systemic growth pro-angiogenic factors or with stem-cell therapy.
• • Ulcers from venous or neuropathic origin.
• • Uncontrolled blood pressure defined as sustained systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg on repeated measures on different days.
• • Acute cardiovascular events (e.g., myocardial infarction, stroke, recent coronary intervention) up to 6 months prior to enrolment.
• • Previous or present history of malignant disease (except basal-cell carcinoma and cervical carcinoma in situ, which was removed without recurrence more than 5 years prior to enrolment).
• • Body mass index \>35.
• • Previously diagnosed as clinically immune-compromised or taking systemic immunosuppressant medication.
• • Patients taking sodium valproate for any indication within the past week.
• • Organ transplant recipient.
• • Inability to comprehend consent information or unlikely to comply with study requirements
• • Participation in another study involving an Investigational Medicinal Product within the 3 months or 5 half-lives of the product (whichever is longer) prior to enrolment.
• • Drug or alcohol abuse.
• • Any other significant disease or abnormalities likely to impact study compliance or interpretation of the results. (If in doubt consult with the ReNeuron study monitor).
• • Patients taking tamoxifen or analogues.