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 range45 Years – 99 Years
SexALL
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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:
✕. 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.