Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Wh… (NCT03886506) | Clinical Trial Compass
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Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
United States
Plain-language summary
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study). In parallel, this expanded access program (EAP) will be conducted to allow the treatment of patients who are ineligible to be enrolled in the PACE study.
The EAP treatment is administered in addition to standard of care of the subjects.PLX-PAD 300×106 cells in a mixture containing 10% DMSO, 5% human serum albumin and Plasma-Lyte, will be administered via 30 IM injections (0.5 mL each) delivered into the leg twice,at 8 weeks interval. The locations of injections of the PLX-PAD are detailed in Appendix 1.
Antihistamine treatment should be given at least 1 hour and no more than 1.5 hours prior to PLXPAD administration to ensure coverage for 24 hours, and as long as necessary post PLX-PAD treatment. Consider treatment with second generation H1 inhibitors such as Cetirizine 10 mg once per day.Subjects will be followed-up until 12 months after the 2nd treatment according to the schedule of routine medical visits at the medical institutions. In addition to this routine follow-up, a phone call will be made 12 months after 2nd treatment to inquire on the occurrence of subsequent intervention, amputation, or death.
Who can participate
Age range
45 Years – 99 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult male or female subjects between ages 45 to 99 years of age at the time of screening.
. Subjects with a diagnosis of PAD due to atherosclerosis at the stage of CLI, with minor tissue loss up to the ankle level (ulcer/s and/or necrosis).
. Ankle pressure (AP)≤70 mmHg or toe pressure (TP)≤ 50 mmHg in the index leg or transcutaneous oxygen pressure (TcPO2)≤ 30 mmHg.
. Subject unsuitable for revascularization (by any method) in the index leg based on unfavorable risk-benefit assessment of the physician investigator. Unsuitability to revascularization should be based on any of the following:
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Medical considerations: subject's comorbidities.
. Signed informed consent form.
Exclusion criteria
. Non-atherosclerotic PAD and vasculitis (e.g., Buerger's disease \[thromboangiitis obliterans\], Takayasu's arteritis, etc.).
. CLI with major tissue loss (Rutherford Category 6) in the index leg. Ulcers from venous or neuropathic origin if not associated with at least one ulcer from arterial origin.
. Evidence of active infection in either leg (e.g., cellulitis, myositis) except localized osteomyelitis secondary to contiguous focus of infection, under antibiotic treatment.
. Subject having undergone surgical/endovascular revascularization or major/minor amputation, in either leg, less than 1 month prior to Screening.
. Planned or potential need for major/minor amputation or any revascularization of either leg within 1 month of EAP entry upon physician's judgment.
. Aortoiliac stenosis or common femoral artery stenosis or otherwise suspicion of inadequate inflow to the index leg at the time of Screening.
. Current evidence or sign supporting an assessment of life expectancy of less than 6 months.
. Stroke or acute myocardial infarction within 3 months prior to Screening.