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

NCT05955235 | Active Not Recruiting

• 1 other identifier: APT2001-LTFU
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 6

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.

Conditions

Pancreatitis, Acute

Keywords

Stem Cell Therapy; SCM-AGH; Pancreatitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of occurrences of Abnormal, clinically significant in laboratory results

  Up to 5 Years

• Number of occurrences of Abnormal, clinically significant in Vital Signs

  Up to 5 Years

Interventions

Not Applicable(Observation Study) OTHER

Not Applicable(Observation Study)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study (ClinicalTrials.gov ID: NCT04189419)

You may qualify if:

• Subjects who provide written informed consent
• Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study

You may not qualify if:

• N/A

Sponsors & Collaborators

• SCM Lifescience Co., LTD.: lead

Study Sites (6)

Soonchunhyang University Hosptial Bucheon

Bucheon-si, Gyenggi-do, 14584, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Location

Dongguk University Ilsan Hospital

Goyang-si, South Korea

Location

Chonnam National University Medical School

Gwangju, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 21, 2023
• Study Start: May 10, 2019
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 28, 2023

Record last verified: 2023-06

Locations

KR (6)