JPRN-jRCT2052230115
Recruiting
Phase 1
An exploratory study of angiogenic therapy by autologous peripheral blood mononuclear cell-bearing ICS-001 transplantation in patients with chronic limb-threatening ischemia (CLTI) with refractory ulcers
Kenichi Yamahara0 sites6 target enrollmentOctober 21, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- CLTI (ASO or Buerger's disease) with refractory ulcer refractory to existing therapy
- Sponsor
- Kenichi Yamahara
- Enrollment
- 6
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who meet all of the following criteria are eligible:
- •(1\) Patients with arteriosclerosis obliterans (ASO) or Buerger's disease
- •(2\) Patients with confirmed occlusion or stenosis by angiography, MRA, or CTA of the lower extremities within 6 months prior to obtaining consent
- •(3\) Patients with Ischemia grade 2 or higher in WIfI classification
- •(4\) Patients with refractory ulcers of Wound grade 1 and Foot Infection grade 1 or lower in the WIfI classification, that are not suitable for revascularization (endovascular treatment or bypass surgery) or that do not heal for more than 4 weeks despite revascularization, Wound grade 1 and Foot Infection grade 1 or lower in the WIfI classification or refractory ulcers
- •(5\) Non\-smoker or patients who have stopped smoking for at least 1 month, and are able to quit smoking throughout the study period (only for Buerger's disease patients)
- •(6\) Patients who are more than 20 years old and less than 85 years old at the time of consent, and whose written consent has been obtained
Exclusion Criteria
- •Patients who meet any of the following criteria should be excluded:
- •(1\) Patients scheduled for major amputation
- •(2\) Patients with Wound grade 0 or 2 or higher in WIfI classification
- •(3\) Patients with Ischema grade 1 or lower in WIfI classification
- •(4\) Patients with Foot infection grade 2 or higher in WIfI classification
- •(5\) Patients who underwent revascularization, sympathectomy/sympathetic ganglion block, cell therapy/gene therapy, or minor amputation for the purpose of CLTI treatment in the lower extremities to which ICS\-001 will be implanted within 4 weeks prior to obtaining consent
- •(6\) Patients with poorly controlled ischemic heart disease or heart failure
- •(7\) Patients with poorly controlled diabetes mellitus
- •(8\) Patients with severe hepatic dysfunction
- •(9\) Patients with severe chronic kidney disease (under 30 mL/min/1\.73 m2 of eGFR )
Outcomes
Primary Outcomes
Not specified
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