Pancreatitis, AcuteNCT05955235
A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
An observational study of Pancreatitis, Acute, run by SCM Lifescience Co., LTD. at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- Not Applicable(Observation Study)
- How many people
- 42 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 10 May 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study (ClinicalTrials.gov ID: NCT04189419)
Who may be able to join
- Subjects who provide written informed consent
- Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study
Who cannot join
- N/A
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Soonchunhyang University Hosptial Bucheon
Bucheon-si, Gyenggi-do, 14584
Kyungpook National University Chilgok Hospital
Daegu
Dongguk University Ilsan Hospital
Goyang-si
Chonnam National University Medical School
Gwangju
Inha University Hospital
Incheon, 22332
Ajou University Hospital
Suwon
About this study
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.
Read the 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.
- Conditions
- Pancreatitis, Acute
- Being tested
- Not Applicable(Observation Study)
- Keywords
- Stem Cell Therapy, SCM-AGH, Pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not Applicable(Observation Study)Other
Not Applicable(Observation Study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety assessment
Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).
Measured: Up to 5 Years
Mortality
Ratio of subjects who died during long-term safety follow-up
Measured: 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
Measured: Up to 5 Years
Secondary outcomes (2)
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
Measured: 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.
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start10 May 2019
- Primary completion20 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCM Lifescience Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955235
- Sponsor's protocol ID
- APT2001-LTFU
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
- ClinicalTrials.gov ID
- NCT05955235
- Acronym / sponsor ID
- APT2001-LTFU
- Conditions
- Pancreatitis, Acute
- Keywords
- Stem Cell Therapy, SCM-AGH, Pancreatitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- SCM Lifescience Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 10 May 2019 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study (ClinicalTrials.gov ID: NCT04189419)
Key inclusion criteria (2 listed)
- Subjects who provide written informed consent
- Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not Applicable(Observation Study)Not Applicable(Observation Study) | Other | – |
Primary outcome
Long-term safety assessment
Time frame: Up to 5 Years
Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).
Mortality
Time frame: 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
Time frame: Up to 5 Years
The number, ratio, and number of cases of malignant tumor formation
2 secondary outcomes
Number of occurrences of Abnormal, clinically significant in laboratory results
Time frame: Up to 5 Years
Number of occurrences of Abnormal, clinically significant in Vital Signs
Time frame: Up to 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Acute, run by SCM Lifescience Co., LTD. at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety assessment (time frame: Up to 5 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.