Regenerative Medicine Advanced Therapy to Evaluate the Safety and Efficacy of ATORM-C after Single Dose in patients with Chronic Radiation Proctitis

Not Applicable

Withdrawn

Conditions: Diseases of the digestive system

Registration Number: KCT0007875

Lead Sponsor: Korea University Anam Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: All

Target Recruitment: 10

Inclusion Criteria

Those who meet all of the following criteria are selected as the subjects for this study.

1. Male and female adults 19 years of age or older, in respect to the date of written consent

2. Those who received radiation therapy to the pelvis for chemotherapy prior to the screening visit with the last radiation therapy more than 3 months prior to the screening visit

3. Those who have been diagnosed with radiation proctitis with confirmed rectal ulcers due to radiation proctitis on screening tests

4. Those who understand the purpose of this clinical study, agree to participate in the clinical study, and abide by the restrictions of the protocol in written consent

Exclusion Criteria

Those who meet any of the following criteria are excluded from this study

1. Those who have been diagnosed as Crohn’s Disease, Ulcerative Colitis, or Infectious Colitis, prior to the date of screening

2. Those diagnosed with colon cancer or rectal cancer prior to the date of screening

3. Those with structural abnormalities of the anus [e.g., anal fistula, anal stenosis, etc.], which make equipment such as proctoscopes and endoscopes difficult

4. Those who have history of mental illness (alcohol or drug addiction) and is deemed to cause problems regarding safety and confusion in interpretation of results

5. Those who test positive for Human Immunodeficiency Virus (HIV) antibody test or hepatitis B surface Antigen (HBsAg), hepatitis C antibody (Anti-Hepatitis C Virus, Anti-HCV) test

6. Those with abnormal findings that are not suitable for participation in this study as a result of screening tests (laboratory tests, electrocardiogram tests, vital signs results, etc.)

7. Pregnant and lactating women

8. Women and men of childbearing potential who plan to become pregnant or do not intend to use appropriate contraceptive methods* during this clinical study

*? hormonal contraceptives, ? implantation of intrauterine device or intrauterine system, ? double blocking method with spermicide [use both male condom and occlusion cap (diaphragm or cervical cap)], ? sterilization (vasectomy, bilateral tubal ligation, etc.)

9. Those who show hypersensitivity to cow protein and fibrin glue or have a history of anaphylaxis

10. Those who participated in other clinical studies or clinical trials within 24 weeks before administration of clinical research drugs

11. Those who are deemed as inappropriate to participate in clinical research by other researchers

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
treatment emergent adverse event(TEAE);the size of the ulcer

Secondary Outcome Measures

Name	Time	Method
Evaluation of local tolerability (appearance abnormalities, evidence of tumor formation, evidence of infection, evidence of immune response, and other local reactions);the grade of the ulcer;the rate of contraction of ulcers;the level of ulcer contraction rate;the grade of telangiectasia