Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)

NCT03746899 | Unknown

• 1 other identifier: PLX-CLI-06
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI patients who cannot participate in the ongoing research trial and who seek exploratory treatment options. This program includes FDA-authorized cost recovery, meaning payment is required to cover a portion of the costs of delivering product and complying with regulatory obligations.

Conditions

Critical Limb Ischemia (CLI)

Keywords

Critical Limb Ischemia (CLI)

Interventions

PLX-PAD BIOLOGICAL

PLX-PAD cell therapy to be administered via 30 IM injections (0.5 mL each) to the index leg leg per treatment, in each of two treatments, 8 weeks apart

Eligibility Criteria

• Age: 45 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Anatomic considerations as: inappropriate target artery, diffuse/extensive tibial and/or peroneal artery lesions, inadequate distal run-off.
• Technical considerations as: inappropriate bypass conduit, failed recent revascularization.
• Medical considerations: subject's comorbidities.
• Signed informed consent form.
• Subjects are not eligible for the ongoing phase III study with PLX-PAD in CLI (PLX-CLI-03) due to at least one of the following criteria:
• Evidence of active localized osteomyelitis secondary to contiguous focus of infection, unless amputation is expected within 1 month post PLX-PAD administration. In case of osteomyelitis, patients must be treated with antibiotics during screening and PLX-PAD administration or as long as there is evidence of active infection.
• Subject on renal replacement therapy or with eGFR \<15 mL/min.
• Current treatment with high dose systemic steroids (prednisone equivalent \>7.5 mg/day) or topical steroids on the index leg.
• History of autologous bone marrow transplantation (if not due to hematologic malignancy) or solid organ transplantation, clinically stable.
• Immunocompromised subjects due to disease for any reason, including immunosuppressive therapy, at screening (for steroid therapy, refer to the criterion c)
• CLI with major tissue loss (Rutherford Category 6) in the contralateral leg.

You may not qualify if:

• 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 ≥70%, 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.
• Severe congestive heart failure symptoms (New York Heart Association \[NYHA\] Stage IV) at screening.
• Life-threatening ventricular arrhythmia - except in subjects with an implantable cardiac defibrillator at screening.
• Uncontrolled severe hypertension during Screening.
• Current or history of proliferative retinopathy.
• Known active Hepatitis B virus or Hepatitis C virus infections at Screening.
• Acquired immunodeficiency syndrome (AIDS), severe uncontrolled inflammatory disease, or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.).
• Subjects at an increased risk of blood clotting or bleeding according to the Physician's judgment.

Sponsors & Collaborators

• WideTrial, Inc.: lead

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Heather Manna

CONTACT

415 691 4556; heather.manna@widetrial.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Last Updated: January 8, 2019

Record last verified: 2019-01