Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
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|ClinicalTrials.gov Identifier: NCT03886506|
Expanded Access Status : Available
First Posted : March 22, 2019
Last Update Posted : July 28, 2020
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.
|Condition or disease||Intervention/treatment|
|Critical Limb Ischemia (CLI)||Biological: PLX-PAD|
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population, Treatment IND/Protocol|
|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|
- Biological: PLX-PAD
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886506
|Contact: John E Rundback||9739476586 ext firstname.lastname@example.org|
|United States, New Jersey|
|OBL-NJ Endovascular & Amputation Prevention, LLC,1429 Broad St., Clifton, NJ||Available|
|Clifton, New Jersey, United States, 07013|
|Contact: John Rundback, Dr 973-947-6586 email@example.com|
|Principal Investigator: John Rundback, Dr|
|Holy Name Medical Center,718 Teaneck Road||Available|
|Teaneck, New Jersey, United States, 07666|
|Contact: John Rundback, Dr. 845-269-0971 firstname.lastname@example.org|
|Principal Investigator: John Rundback, Dr.|