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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05955235

Enrollment

Registered

2023-07-21

Start date

2019-05-10

Completion date

2026-12-31

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis, Acute

Keywords

Stem Cell Therapy, SCM-AGH, Pancreatitis

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.

Interventions

OTHERNot Applicable(Observation Study)

Not Applicable(Observation Study)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of occurrences of Abnormal, clinically significant in laboratory results	Up to 5 Years	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
Number of occurrences of Abnormal, clinically significant in Vital Signs	Up to 5 Years	Measure systolic blood pressure, diastolic blood pressure, pulse, and body temperature.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026