non-healing lower extremity ulcers
Conditions
Interventions
While continuing existing standard therapy for refractory ischemic lower extremity ulcers, RE-01 cells will be administered at a total of 8 to 60 sites (with a total dose of 0.26 to 2*10^7 cells), thr
Sponsors
Matsubara Shinobu
Tanaka Rica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age of 18-85 years 2) WIfI wound grade 1-2, size 0.5 cm^2<=,<=10 cm^2 If there are ulcers on both limbs, the limb with the largest ulcer will be treated. 3) Patients diagnosed with Buerger's disease or collagen diseases [including systemic sclerosis, systemic lupus erythematosus(SLE), dermatomyositis, rheumatoid arthritis, malignant rheumatoid arthritis, and various types of vasculitis (such as polyarteritis nodosa, microscopic polyangiitis, granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, lupus vasculitis, rheumatoid vasculitis, Takayasu arteritis, and sarcoid vasculitis, etc.)], and additionally diagnosed with ischemic ulcers caused by vasculitis. 4) Patients whose primary condition (the disease causing lower limb ischemia) is well-controlled. 5) Patients in whom, despite 4 weeks of standard therapy for refractory ischemic lower extremity ulcers at the time of consent acquisition, the reduction rate of the largest ulcer area remains less than 50% compared to before treatment initiation, and closure by relatively simple procedures (such as suturing, skin grafting, or local flaps) is judged unlikely even if standard therapy is continued. 6) Patients who cannot undergo revascularization surgery, or the maximum ulcer area reduction rate is less than 50% at 4 weeks after revascularization surgery. 7) Patients who have not smoked within 3 months before consent acquisition and agree to refrain from smoking during the trial period. 8) Provided written consent 9) Comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1) Ischemic ulcer or the ulcers due to Buerger's disease or collagen disease in the other limb, which is non healing or is predicted to have a major amputation 2) Infected ulcer (WIfI infection grade 2= 8.0% 13) Severe systemic infection (CRP>5mg/dL) 14) Hemoglobin level of less than 8g/dL 15) Patients who are unable to stand even with a prosthesis due to prior major amputation on the contralateral limb. 16) Patients with severe cardiac dysfunction (NYHA class 3 or 4, or left ventricular ejection fraction less than 35% on echocardiography at screening). 17) Patients receiving drugs with angiogenesis inhibitory effects for the treatment of active diabetic proliferative retinopathy, etc. 18) Patients with malignant tumors or within 5 years after curing malignancy (within 10 years for breast cancer). (However, patients with adequately treated non-melanoma skin cancer or cervical carcinoma in situ may participate in the trial.) 19) Patients with hematological diseases such as hematologic malignancies, myeloproliferative disorders, or myelodysplastic syndromes. 20) Patients with a history of hypersensitivity to the biological raw materials (human serum albumin, fetal bovine serum) used in the investigational product (RE-01). 21) Pregnant or lactating women, women who may become pregnant and tested positive on a pregnancy test at screening, or men or women unwilling to use contraception during the clinical trial period. 22) Patients who test positive for HIV, active HBV, HCV, HTLV, or syphilis during screening examinations. 23) Patients who have previously received the investigational product (RE-01) or its predecessor (MNC-QQ cells). 24) Patients who are considered to have a life expectancy of less than one year due to comorbidities, etc. 25) Patients with comorbidities such as dementia that are deemed likely to significantly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects Who Responded by 5 Months After Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)The proportion of subjects who responded effectively within 5 months from baseline (2)Number of days from baseline to complete wound healing (3)Duration from baseline to major amputation, revascularization, or death (4)Duration from baseline to major amputation (5)Duration from baseline to major amputation or death (6)Status of amputation procedures (7)Changes in scores based on the Wound, Ischemia, and Foot Infection (WIfI) classification from baseline to each evaluation point (8)Duration from baseline to surgical procedures for stump formation, flap creation, or skin graft closure (9)Change in lower limb physiological function test results from baseline to each evaluation point (10)Change in lower limb ischemic resting pain from baseline to each evaluation point using the visual analogue scale (VAS) and numerical rating scales (NRS) (11)Amount of analgesic use for alleviating resting pain in the target limb ulcer from baseline to each evaluation point (12)Change and reduction rate of ulcer size from baseline to each evaluation point (13)Change in ulcer depth from baseline to each evaluation point (14)Change in the number of ulcers from baseline to each evaluation point (15)Duration from baseline to the earliest occurrence of a new ulcer (16)Change in vascular quality of life questionnaire (VascuQOL) score from baseline to each evaluation point (17)Change in EuroQol 5 Dimensions 5-Level (EQ-5D-5L) score from baseline to each evaluation point (18)Success rate of investigational product manufacturing Safety Evaluation (1)Incidence of adverse events (2)Clinical laboratory values (3)Vital signs (body temperature, pulse rate, systolic/diastolic blood pressure) (4)Body weight (5)12-lead electrocardiogram | — |
Contacts
Public ContactShinobu Matsubara
Juntendo University Hospital
Outcome results
None listed