non-healing lower extremity ulcers
Conditions
Interventions
Three times at 4 weeks intervals. One dose is a total of 2 * 10^7 RE-01 cells via injections at 60 sites.
Sponsors
Matsubara Shinobu
Tanaka Rica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age of 18-80 years 2)WIfI wound grade 1-2, size 0.5 cm^2<=, <=10 cm^2 If there are ulcers one both limbs, only one limb with the largest ulcer will be treated. 3)A diagnosis of 1.Buerger's disease or 2.Collagen disease(Systemic sclerosis, Systemic lupus erythematosus(SLE), Dermatomyositis, Rheumatoid arthritis(RA), Malignant reheumatoid arthritis(MRA), and various Vasculitis including Polyarteritis nodosa(PAN), Microscopic polyangiitis(MPA), Granulomatosis with polyangiitis(GPA), Eosinophilic granulomatosis with polyangiitis(EGPA), Lupus vasculitis, Rheumatoid vasculitis, Takayasu arteritis, and Sarcoid vasculutis) by the specialist of collagen disease. Ischemic ulcers due to vasculitis diagnosed by the specialist of Collagen disease, Cardiovascular medicine, Plastic surgery or Vascular surgery 4)Patients under good control of the primary disease 5)Non healing foot ulcers after more than 4 weeks standard treatment, with <50% wound closure and cannot be closed by simple procedures(primary closure, skin graft or local flap, etc.) 6)No smoking more than 3 months before enrollment and agree to stop smoking during the clinical trial
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 28.0% 11)Severe systemic infection (CRP>5mg/dL) 12)Hemoglobin level of less than 8g/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of adverse events clinical data vital sign body weight | — |
Contacts
Public ContactMiyuki Omura
Juntendo Hospital
Outcome results
None listed