and do not have the option of a revascularization treatment., and/or had a revascularisation with continued presence of smaller vessel (microvasculature) disease, Peripherial arterial disease (PAD) & Chronic-Limb Threatening Ischemia (CLTI) patients who have not responded to standard pharmacological treatment or control of risk factors
Conditions
Brief summary
The primary safety endpoints will consist of: • Incidence and proportion of incidence between treatment arms of adverse events of specific interest (AESI) and injection-related AE • Incidence of serious adverse events (SAEs) including SAEs related or probably related to the treatment • Vital signs and physical examination • Safety laboratory values of hematology, blood chemistry, and urinalysis • Local tolerability (injection site reaction), The primary efficacy endpoints will consist of: • Major amputation (below or above the knee) rate at Month 12 • Major amputation-free survival (AFS) rate at Month 12
Interventions
DRUGX-vivo 15 (serum-free growth medium manufactured under gmp and commercially available from Lonza)
Sponsors
Biogencell Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoints will consist of: • Incidence and proportion of incidence between treatment arms of adverse events of specific interest (AESI) and injection-related AE • Incidence of serious adverse events (SAEs) including SAEs related or probably related to the treatment • Vital signs and physical examination • Safety laboratory values of hematology, blood chemistry, and urinalysis • Local tolerability (injection site reaction), The primary efficacy endpoints will consist of: • Major amputation (below or above the knee) rate at Month 12 • Major amputation-free survival (AFS) rate at Month 12 | — |
Countries
Belgium
Outcome results
None listed