ICS-001-1

Phase 1

Recruiting

• Conditions: CLTI (ASO or Buerger's disease) with refractory ulcer refractory to existing therapy

• Registration Number: JPRN-jRCT2052230115
• Lead Sponsor: Kenichi Yamahara

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-21
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

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 )
(10) Patients undergoing hemodialysis or peritoneal dialysis or post renal transplantation
(11) Patients with a history of serious hypersensitivity or adverse reactions to Filgrastim (Gran), Plerixafol (Mozobil), and Apheresis
(12) Patients with concomitant or pre-existing interstitial pneumonia
(13) Patients with leukemia, myeloproliferative disorders, or myelodysplastic syndrome
(14) Patients who have undergone percutaneous coronary intervention within 2 months prior to obtaining consent
(15) Patients complicated with malignant tumors
(16) Patients with untreated proliferative diabetic retinopathy (modified Davis classification: proliferative retinopathy)
(17) Patients with infectious diseases associated with a fever of 38 degree or higher
(18) Patients with hypoalbuminemia (albumin level less than 3.0 g/dL)
(19) Patients with low BMI (under 18)
(20) Patients with claudication, pain at rest, skin ulcer, or gangrene due to other factors not caused by the primary disease
(21) Patients with psychiatric disorders that are difficult to control
(22) Patients with clinically problematic splenomegaly
(23) Patients who are participating in other clinical trials or who have not completed a previous clinical trial more than 3 months after the completion of the previous trial
(24) Pregnant women, lactating women, female patients who may be pregnant or planning to become pregnant by the end of the study period, or male patients whose partners wish to become pregnant
(25) Patients who are unlikely to survive beyond 12 months after the date of consent
(26) Other patients who are judged by the investigator or subinvestigator to be inappropriate as subjects for this clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events determined to be causally related to protocol treatments defined in this study protocol (Filgrastim (Gran), Plerixafor (Mozovir), apheresis, anesthesia, ICS-001-autologous peripheral blood mononuclear cell-transplantation procedure, peripheral blood mononuclear cells, ICS-001)