ADR-04

JRCT ID: jRCT2073220005

Registered date:23/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Highly chronic lower extremity deficiency blood included
• Date of first enrollment: 23/04/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Patients with comprehensive advanced chronic lower extremity ischemia will receive 200 million cells of ADR-001 once a week for 2 weeks, repeated weekly.

Outcome(s)

• Primary Outcome: Safety (occurrence of adverse events)
• Secondary Outcome: Efficacy (size of ischemic ulcer, ABI, TBI, tcPO2, SPP, formation of angiogenesis by lower extremity angiography, survival rate in limb amputation avoidance status)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have obtained written consent from the patient himself/herself
2) Patients who are 18 years of age or older at the time of consent
3) Patients with inadequate response to standard drug therapy
(Patients treated with beperminogen perplasmin have been administered for 4 weeks and are not eligible to receive beperminogen perplasmin.
(Patients judged to have inadequate response)
4) Patients with PAD and any of the following clinical symptoms
(1) Foot ulcers or ulcers on any of the lower extremities that have existed for at least 2 weeks
(2) Gangrene present in the lower extremity or any part of the foot
5) Patients whose condition of the target limb at the time of preadministration examination meets all of the following conditions
(1) Clinical findings: small area of tissue loss - ischemia of the entire foot with refractory ulceration and localized necrosis.
(2) Objective criteria: resting ankle blood pressure less than 60 mmHg and toe blood pressure less than 40 mmHg

Exclude criteria

1) Patients with simple venous ulcers, simple wounds, traumatic wounds, acute lower extremity ischemia, ischemic symptoms within 2 weeks, embolism
2) Patients with invasive infections (osteomyelitis, cellulitis, lymphangitis, etc.) in the target limb that are difficult to control with antimicrobial agents
3) Patients with deep ulcers with exposed bones, joints or tendons
4) Patients with rest pain, ulceration, or necrosis due to spinal cord disease or joint disease
5) Patients who have indications for surgical revascularization or endovascular treatment of the target limb, or who have shown improvement in blood flow with these existing treatments.
6) Patients who have undergone surgical revascularization or endovascular treatment within 1 month prior to obtaining consent
7) Patients with proliferative diabetic retinopathy (untreated proliferative retinopathy, mid- and late-stage proliferative retinopathy) or neovascular type age-related macular degeneration
8) Patients with concomitant malignancy or a history of malignancy within 3 years prior to obtaining consent
9) Patients with severe cardiac, respiratory, or other comorbidities that make them unsuitable for inclusion in this study, such as the following
(1) NYHA Class III-IV congestive heart failure
(2) Active coronary artery disease
(3) Uncontrolled hypertension
(4) Grade 2 or higher arrhythmia in CTCAE ver 5.0, etc.
10) Patients with myocardial infarction, cerebral infarction, cerebral hemorrhage, or transient ischemic attack within 3 months prior to obtaining consent
11) Patients with allergy or history of allergy to contrast media
12) Patients allergic or with a history of allergy to penicillin antibiotics, aminoglycoside antibiotics, or dimethyl sulfoxide (DMSO)
13) Patients with concomitant psychiatric disorders deemed to affect obtaining consent
14) Patients with drug abuse or alcohol dependence
15) Pregnant women, lactating women, women who may be pregnant or men and women who cannot agree to use contraception under the guidance of the investigator or subinvestigator during the study period
16) Patients who have participated in other clinical trials such as clinical trials, clinical research and post-marketing clinical trials within 4 weeks prior to obtaining consent
17) Other patients deemed ineligible by the investigator (subinvestigator)

Related Information

• Primary Sponsor: furukawa kojiro