A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study

Study Overview
=================
Brief Summary
-----------------
This is a long-term safety follow-up study of the Phase I/IIa multicenter study of SCM-AGH in subjects with moderate to severe acute pancreatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol SCM-APT2001 (ClinicalTrials.gov ID: NCT04189419) will be eligible for this long-term follow-up protocol.

Detailed Description
-----------------
Subjects who meet all eligibility criteria for Long Term Follow-Up(LTFU) study participation at the SCM-APT2001 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.

Official Title
-----------------
A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study

Conditions
-----------------
Pancreatitis, Acute

Intervention / Treatment
-----------------
* Other: Not Applicable(Observation Study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who provide written informed consent Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Not Applicable(Observation Study)|Not Applicable(Observation Study)|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety assessment | Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event). | Up to 5 Years | 
| Mortality | Ratio of subjects who died during long-term safety follow-up | Up to 5 Years | 
| Ratio of subjects with malignant tumors formed during the long-term safety follow-up period | The number, ratio, and number of cases of malignant tumor formation | Up to 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of occurrences of Abnormal, clinically significant in laboratory results | Perform if necessary. Hematology: RBC, Hemoglobin, Hematocrit, Platelet count, WBC with Differential Count Chemistry: Na, K, Ca, Cl, BUN, Creatinine, Uric acid, Total bilirubin, Albumin, Total protein, ALT, AST, r-GT, ALP, LDH, glucose, Total cholesterol, Triglyceride, C-reactive protein Urinalysis: Protein, Glucose, Urobilinogen, WBC, RBC Blood coagulation test: aPTT, PT | Up to 5 Years | 
| Number of occurrences of Abnormal, clinically significant in Vital Signs | Measure systolic blood pressure, diastolic blood pressure, pulse, and body temperature. | Up to 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem Cell Therapy, SCM-AGH, Pancreatitis