Critical Limb Ischemia (CLI) Clinical Trial
Official title:
Expanded Access to Provide Intramuscular Injections of PLX-PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
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.
n/a
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