None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Experimental group: Depending on the ulcer area of the subject, ATORM-C (0.1 to 1.0 x 10^7 cells) is mixed with the Variflast-Picombic set and applied to the lesion thr
Sponsors
Dongguk University Ilsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women 19 years of age or older 2) A person who received radiation therapy in the pelvis as chemotherapy prior to the screening visit date, and whose last radiotherapy date is more than 3 months prior to the screening visit date 3) A person diagnosed with radiation colitis prior to the screening visit date 4) A person who has been evaluated with an endoscopic score of 3 or more during screening 5) A person who voluntarily decided to participate and agreed in writing after hearing an explanation of the characteristics of this clinical study and ATORM-C
Exclusion criteria
Exclusion criteria: 1) As of the screening visit date, any one of Crohn's Disease, Ulcerative Colitis, or Infectious Colitis has been identified 2) A person diagnosed with colorectal cancer or rectal cancer before the screening visit date 3) A person who has difficulty in using equipment such as rectoscope and endoscopy due to structural abnormalities in the anus (e.g., an anal fistula, an anal stenosis, etc.) 4) A person who had stage 4 of a malignant tumor in the pelvis treated with radiation therapy 5) A person who is deemed to have a mental illness (alcohol or drug addiction) that may cause a problem in the safety of the subject or cause confusion in the interpretation of clinical research results 6) A person who has a history of hypersensitivity or hypersensitivity to fibrin-glue or components constituting this ATORM-C, such as antibiotics (gentamicin, streptomycin, amphotericin B) 7) Uncontrolled blood coagulation disorder (e.g., severe hemophilia) 8) Severe renal disorders (e.g., chronic renal failure, hemodialysis, peritoneal dialysis, etc.) 9) Severe liver disorders (e.g., cirrhosis, acute and chronic liver disease, etc.) 10) Myocardial infarction, unstable angina, or cerebrovascular disease within 6 months based on screening (e.g., cerebral infarction, cerebral hemorrhage, transient ischemic attack, etc.) 11) Severe clinically significant infections (if continuous use of antibiotics or immunotherapy is required) 12) As a result of the screening test, the person in charge (or delegated person) determines that there are clinically meaningful abnormal findings that are not suitable for participation in this study - AST, ALT = 3 times normal upper limit - eGFR (CKD-EPI) 1.5 - platelet count < 50,000/mm3 13) Pregnant and lactating women 14) The person or spouse or partner has not agreed to -Hormonal contraception, intrauterine devices (IUDs, IUSs), infertility (intracheal surgery, tubular ligation), or double blocking (multiple choices among male condoms, cervical caps, contraceptive septum, contraceptive sponges) are highly effective contraception during the clinical study period (until the end of the visit) 15) Those who show hypersensitivity to right protein and fibrin glue or have a history of anaphylaxis 16) Those who participated in other clinical studies or clinical trials within 24 weeks of screening criteria (excluding those who participated in observational studies or non-interactive studies) 17) A person who is deemed unsuitable for participation in clinical research by another research director (or delegated person)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(Adverse event, physical examination, vital signs, electrocardiogram, laboratory test) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the size of target ulcers (based on measured length of the longest axis) at 4, 12, and 24 weeks after administration compared to baseline;Changes in disease severity scores at 4, 12, and 24 weeks after administration versus baseline;Changes in endoscopic scores at 4, 12, and 24 weeks after administration compared to baseline ;Changes in the histopathological disease activity score of Target ulcers at 24 weeks after administration versus baseline ;Changes and rates of change in hemoglobin at 4, 12, and 24 weeks after administration compared to baseline (%) ;Percentage (%) and number of subjects who received blood transfusions during the clinical study period;Percentage (%) and number of study subjects who visited the emergency room due to chronic radiation colitis during the clinical study period | — |
Countries
Korea, Republic of
Contacts
Public ContactYun Jeong Lim
Dongguk University Ilsan Hospital
Outcome results
None listed