Status:
COMPLETED
Safety Trial Of CTX Cells In Patients With Lower Limb Ischaemia
Lead Sponsor:
ReNeuron Limited
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The primary objective of the Phase I ascending dose trial is to investigate the safety and tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product, CTX, in patients ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01916369
Start Date
April 1 2014
End Date
January 16 2018
Last Update
January 31 2018
Active Locations (1)
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1
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 4HN