Neuropathic Pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Individuals diagnosed with neuropathic pain (2) Individuals whose symptoms have not improved with oral medication (3) Individuals between the ages of 20 and 80 (4) Individuals who have provided written informed consent (5) Individuals who are able to participate in safety evaluation tests and related procedures
Exclusion criteria
Exclusion criteria: (1) Individuals with an allergy to anesthetics used during fat collection (2) Individuals undergoing dialysis (3) Individuals who are pregnant (4) Individuals who are currently hospitalized (5) Individuals deemed by the principal investigator to have abnormal vital signs or blood test results (e.g., liver or kidney function) outside the normal range (6) Individuals who test positive for infectious disease screening (HBs antigen, HCV antigen/antibody, HIV antigen/antibody, HTLV-1 antigen/antibody, and syphilis (7) Individuals with sepsis or suspected sepsis (8) Those with a history of malignant tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest X-ray Medical interview (physical examination) This test is performed 2 to 3 hours after intravenous administration of autologous adipose-derived neural progenitor cells to confirm that no adverse events caused by the administration of specific cell products have occurred. | — |
Secondary
| Measure | Time frame |
|---|---|
| Medical Examination and Interview Height and weight, treatment history, comorbidities, medical history, physical findings, body temperature, blood pressure, pulse, oxygen saturation, pain intensity (VAS, NRS, FRS),etc. Blood Tests General hematological tests including red blood cells, white blood cells, and platelets, and biochemical tests including liver and kidney function Imaging tests: chest X-ray, electrocardiogram(ECG) The above will be performed before administration and after the first intravenous administration (4 weeks, 8 weeks, 12 weeks,16 weeks, 20weeks) to confirm that no adverse events caused by the administration of specific cell products have occurred. | — |
Countries
Japan
Contacts
Kougekai Medical Corporation