Pancreatitis, AcutePhase 1/2NCT04189419
Safety and Efficacy of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis
A Phase 1/2 study testing SCM-AGH in people with Pancreatitis, Acute, run by SCM Lifescience Co., LTD. at 7 sites in South Korea.
Trial summary
This study consists of two phases (Phase I and Phase IIa). Phase IIa will be conducted sequentially after the safety of SCM-AGH is secured in Phase I. Phase I: Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design) for Severe Acute Pancreatitis Phase II: Multicenter in Korea, Randomized… 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?
- SCM-AGH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 12 Aug 2019to 15 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=19 years of age
- [Phase I]
- Patient with acute pancreatitis with organ failure which has been determined as severe acute pancreatitis prior to assignment(randomization) (1) Organ failure: 2 points of Modified Marshall Score in one or more of the respiratory system, renal system and cardiovascular system (2) Acute pancreatitis: at least 2 of the following 3 conditions are met
- Typical abdominal pain indicating acute pancreatitis
- Increased blood level of pancreatic enzyme (amylase or lipase >= three times of upper limit of normal)
- Finding acute pancreatitis in imaging test (contrast enhanced computerized tomography, abdominal magnetic resonance imaging, or abdominal sonography) (3) Severe: at least 1 of following organ failures lasting for > 48 hours according to the 2012 Atlanta Classification
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- Respiratory system: PaO2/FiO2 =< 300
- Renal system: Creatinine >= 1.9 mg/dL
- Cardiovascular system: low systolic blood pressure persists despite fluid replacement (SBP < 90 mmHg. off inotropic support)
- Patient who or whose representative voluntarily agrees to participate in this study and has given a written informed consent
- [Phase II] 2) Patient with acute pancreatitis with organ failure or CTSI score >= 4 which has been determined as moderate to severe acute pancreatitis prior to assignment(randomization)
- Organ failure: 2 points of Modified Marshall Score in one or more of the respiratory system, renal system and cardiovascular system
- CTSI: Sum of Balthazar grade and Necrosis score. CTSI 1-3: Mild / CTSI 4-6: Moderate / CTSI 7-10: Severe
- Acute pancreatitis: at least 2 of the following 3 conditions are met
- a.Typical abdominal pain indicating acute pancreatitis b. Increased blood level of pancreatic enzyme (amylase or lipase >= three times of upper limit of normal) c. Finding acute pancreatitis in imaging test (contrast enhanced computerized tomography, abdominal magnetic resonance imaging, or abdominal sonography)
- Moderate to Severe at least 1 of following organ failures lasting according to the 2012 Atlanta Classification - Respiratory system: PaO2/FiO2 =< 300 - Renal system: Creatinine >= 1.9 mg/dL
- Cardiovascular system: low systolic blood pressure persists despite fluid replacement (SBP < 90 mmHg. off inotropic support)
- [Moderately Severe]
- organ failures lasting for < 48 hours according to the 2012 Atlanta Classification or CTSI 4-8,
- [Severe]
- organ failures lasting for >= 48 hours according to the 2012 Atlanta Classification
- 3) Patient who or whose representative voluntarily agrees to participate in this study and has given a written informed consent
Who cannot join
- Patient with allergic or hypersensitivity reaction to investigational product, drug of similar class or ingredients (bovine serum, dimethyl sulfoxide)
- Patient who cannot undergo contrast-enhanced computerized tomography due to allergic reaction to contrast medium
- Patient past >72 hours after the onset of organ failure at assignment (randomization)
- Patient with condition that may develop acute abdominal pain
- Patient with pancreatitis resulting from trauma, surgery, or neoplasm
- Patient with unstable ventilation due to underlying disease other than pancreatitis
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- Patient with active infection such as non-pancreatic infection, septicemia, or pneumonia resulting from other disease
- Patient requiring urgent surgery within 7 days
- Patient with severe comorbidity (chronic renal disease, hepatic cirrhosis, chronic obstructive lung disease, bronchial asthma, congestive heart failure)
- Patient with evidence of chronic pancreatitis (recurrent, obstructive and chronic; autoimmune and chronic; marked pancreatic insufficiency such as steatorrhea)
- Pregnant woman, breastfeeding woman, or woman and man of reproductive potential not willing to use contraceptive measures during the study period
- Patient who received other investigational product/device within 30 days prior to screening
- Patient not eligible for study participation in the opinion of the investigator
- Patient with current or past malignancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 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
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis
This study consists of two phases (Phase I and Phase IIa). Phase IIa will be conducted sequentially after the safety of SCM-AGH is secured in Phase I.
- Phase I: Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design) for Severe Acute Pancreatitis
- Phase II: Multicenter in Korea, Randomized, Double-blind, 2-arm, Placebo-controlled, Parallel arm for Moderate to Severe Acute Pancreatitis
Read the detailed description
Phase I (Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design): Three and up to six patients with severe Acute Pancreatitis are planned to recruit from 12 sites in Korea, but additional three patients can be enrolled by an assessment of Adverse Drug Reaction(ADR) from first three subjects .
Subjects will be administered with SCM-AGH as an intravenous (IV) infusion once a day for 3 days. Efficacy and safety are assessed daily for the first week, and then weekly on 3 occasions (Day 14, 21, and 28). Survival is followed up until Day 90.
Phase II (Multicenter in Korea, Randomized, Double-blind, 2-arm, Placebo-controlled, Parallel arm): Eligible patients will be randomized to the SCM-AGH group or placebo group at 1:1 ratio. Total 36 patients with Moderate to Severe Acute Pancreatitis are planned to be enrolled from 12 sites in Korea. Subjects will receive SCM-AGH on Day 0, 1, and 2. Existing standard of care is permitted. Efficacy and safety are assessed daily for the first week, and then weekly on 3 occasions (Day 14, 21, and 28). Survival is followed up until Day 90.
- Conditions
- Pancreatitis, Acute
- Being tested
- SCM-AGH, Placebo
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCM-AGHBiological
SCM-AGH will be administrated once a day for 3 days(D0, D1 and D2).
PlaceboOther
Placebo will be administrated once a day for 3 days(D0, D1 and D2).
| Study group | Role | What they receive |
|---|---|---|
| SCM-AGH | Experimental | * Ingredient: Allogeneic human bone marrow derived mesenchymal stem cells
* Dose: 1x10^6 cells/Kg Receives: Biological: SCM-AGH |
| Placebo | Placebo comparator | IV infusion. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in modified Marshall score on Day 7 for organ failure subject
The modified Marshall score is the scoring system to define the organ failure. The score is based on three different scores, one each for the respiratory, cardiovascular and renal. the modified Marshall score is >2 through the respiratory, renal or cardiovascular system, it is called organ failure.
Measured: Day 7
The change from baseline in CTSI Score on Day 28
CTSI is scoring system to define the severity of acute pancreatitis. (4-6: Moderate, 7-10: Severe)
Measured: Day 28 for CTSI Subject
Secondary outcomes (13)
Percentage of subjects whose organ failure was resolved at 3 days, 7 days, 14 days and 28 days
Measured: Day 3, Day 7, Day 14 and Day 28 or the day of discharge
The change from baseline in modified Marshall score at each assessment point up to Day 28
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28
The change from baseline in sequential organ failure assessment (SOFA) at each assessment point up to Day 28
SOFA score is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28 or the day of discharge
Duration of Systemic inflammatory response syndrome (SIRS)
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28 or the day of discharge
Time to resolution of organ failure
The modified marshall score is 0 or 1 for all organ in respiratory, cardiovascular and renal.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28
The change from baseline value of C-Reactive Protein(CRP) which is inflammatory marker on Day 1, 2, 3, 5, 7, and 14
Measured: Day 1, Day 2, Day 3, Day 5, Day 7, Day 14
Change from baseline in inflammatory markers(change of Tumor Necrosis Factor(TNF)-α, interleukin(IL)-6, TGF-b1, CCL2 and Lymphocyte count ratio) on Day 1, 2, 3, 5, 7, and 14
Measured: Day 1, Day 2, Day 3, Day 5, Day 7, Day 14
Duration of intensive care unit (ICU) stay
Number of days for stay duration at ICU. The duration is from the day of hospitalization to day of discharge.
Measured: Day 28 or the day of discharge
The change from baseline in Computed Tomography Severity Index(CTSI) on Day 28
CTSI is the sum of Balthazar grade and necrosis score. The scoring is defined by evaluation of abdominal Computed Tomography(CT).
Measured: Day 28 or the day of discharge
Incidence of pancreatic complication
Pancreatic complication will be evaluated by abdominal CT.
Measured: Day 28 or the day of discharge
Requirement of drainage or surgery
Requirement of drainage due to intra-abdominal catastrophe or necrosis and surgery due to hemorrhage, perforation or abdominal compartment syndrome will be evaluated until Day 28.
Measured: Day 28 or the day of discharge
Rate of infection
The even of infection such as infected pancreatic necrosis, bacteremia and pneumonia. The several tests for diagnosis can be conducted per investigator's decision.
Measured: Day 28 or the day of discharge
Mortality on Day 28 and 90
Measured: Day 28 or the day of discharge and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start12 Aug 2019
- Primary completion14 Jan 2022
- Study completion15 Mar 2022
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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I: Multicenter in Korea, Non-Randomized, Open-label, Single arm, 3+3 design Phase II: Multicenter in Korea, Randomized, Double-blind, Placebo-controlled, 2-arm, Parallel Group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCM Lifescience Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Nah Lee, Principal investigator, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189419
- Sponsor's protocol ID
- APT2001
- Status last verified
- May 2022
- First submitted
- 4 Dec 2019
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT04189419
- Acronym / sponsor ID
- APT2001
- Conditions
- Pancreatitis, Acute
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SCM Lifescience Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 6 Dec 2019 (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 study consists of two phases (Phase I and Phase IIa). Phase IIa will be conducted sequentially after the safety of SCM-AGH is secured in Phase I.
- Phase I: Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design) for Severe Acute Pancreatitis
- Phase II: Multicenter in Korea, Randomized, Double-blind, 2-arm, Placebo-controlled, Parallel arm for Moderate to Severe Acute Pancreatitis
Detailed description
Phase I (Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design): Three and up to six patients with severe Acute Pancreatitis are planned to recruit from 12 sites in Korea, but additional three patients can be enrolled by an assessment of Adverse Drug Reaction(ADR) from first three subjects .
Subjects will be administered with SCM-AGH as an intravenous (IV) infusion once a day for 3 days. Efficacy and safety are assessed daily for the first week, and then weekly on 3 occasions (Day 14, 21, and 28). Survival is followed up until Day 90.
Phase II (Multicenter in Korea, Randomized, Double-blind, 2-arm, Placebo-controlled, Parallel arm): Eligible patients will be randomized to the SCM-AGH group or placebo group at 1:1 ratio. Total 36 patients with Moderate to Severe Acute Pancreatitis are planned to be enrolled from 12 sites in Korea. Subjects will receive SCM-AGH on Day 0, 1, and 2. Existing standard of care is permitted. Efficacy and safety are assessed daily for the first week, and then weekly on 3 occasions (Day 14, 21, and 28). Survival is followed up until Day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I: Multicenter in Korea, Non-Randomized, Open-label, Single arm, 3+3 design Phase II: Multicenter in Korea, Randomized, Double-blind, Placebo-controlled, 2-arm, Parallel Group
| Arm | Type | Receives |
|---|---|---|
| SCM-AGH | Experimental | Biological: SCM-AGH* Ingredient: Allogeneic human bone marrow derived mesenchymal stem cells * Dose: 1x10^6 cells/Kg |
| Placebo | Placebo comparator | Other: PlaceboIV infusion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- >=19 years of age
- [Phase I]
- Patient with acute pancreatitis with organ failure which has been determined as severe acute pancreatitis prior to assignment(randomization) (1) Organ failure: 2 points of Modified Marshall Score in one or more of the respiratory system, renal system and cardiovascular system (2) Acute pancreatitis: at least 2 of the following 3 conditions are met
- Patient who or whose representative voluntarily agrees to participate in this study and has given a written informed consent
- [Phase II] 2) Patient with acute pancreatitis with organ failure or CTSI score >= 4 which has been determined as moderate to severe acute pancreatitis prior to assignment(randomization)
Key exclusion criteria (14 listed)
- Patient with allergic or hypersensitivity reaction to investigational product, drug of similar class or ingredients (bovine serum, dimethyl sulfoxide)
- Patient who cannot undergo contrast-enhanced computerized tomography due to allergic reaction to contrast medium
- Patient past >72 hours after the onset of organ failure at assignment (randomization)
- Patient with condition that may develop acute abdominal pain
- Patient with pancreatitis resulting from trauma, surgery, or neoplasm
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 |
|---|---|---|
| SCM-AGHSCM-AGH will be administrated once a day for 3 days(D0, D1 and D2). | Biological | SCM-AGH |
| PlaceboPlacebo will be administrated once a day for 3 days(D0, D1 and D2). | Other | Placebo |
Primary outcome
The change from baseline in modified Marshall score on Day 7 for organ failure subject
Time frame: Day 7
The modified Marshall score is the scoring system to define the organ failure. The score is based on three different scores, one each for the respiratory, cardiovascular and renal. the modified Marshall score is >2 through the respiratory, renal or cardiovascular system, it is called organ failure.
The change from baseline in CTSI Score on Day 28
Time frame: Day 28 for CTSI Subject
CTSI is scoring system to define the severity of acute pancreatitis. (4-6: Moderate, 7-10: Severe)
13 secondary outcomes
Percentage of subjects whose organ failure was resolved at 3 days, 7 days, 14 days and 28 days
Time frame: Day 3, Day 7, Day 14 and Day 28 or the day of discharge
The change from baseline in modified Marshall score at each assessment point up to Day 28
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28
The change from baseline in sequential organ failure assessment (SOFA) at each assessment point up to Day 28
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28 or the day of discharge
Duration of Systemic inflammatory response syndrome (SIRS)
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28 or the day of discharge
Time to resolution of organ failure
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28
The change from baseline value of C-Reactive Protein(CRP) which is inflammatory marker on Day 1, 2, 3, 5, 7, and 14
Time frame: Day 1, Day 2, Day 3, Day 5, Day 7, Day 14
Change from baseline in inflammatory markers(change of Tumor Necrosis Factor(TNF)-α, interleukin(IL)-6, TGF-b1, CCL2 and Lymphocyte count ratio) on Day 1, 2, 3, 5, 7, and 14
Time frame: Day 1, Day 2, Day 3, Day 5, Day 7, Day 14
Duration of intensive care unit (ICU) stay
Time frame: Day 28 or the day of discharge
The change from baseline in Computed Tomography Severity Index(CTSI) on Day 28
Time frame: Day 28 or the day of discharge
Incidence of pancreatic complication
Time frame: Day 28 or the day of discharge
Requirement of drainage or surgery
Time frame: Day 28 or the day of discharge
Rate of infection
Time frame: Day 28 or the day of discharge
Mortality on Day 28 and 90
Time frame: Day 28 or the day of discharge and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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.
Yun Nah Lee principal investigator
Soon Chun Hyang University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCM-AGH in people with Pancreatitis, Acute, run by SCM Lifescience Co., LTD. at 7 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 22 inclusion and 14 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: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change from baseline in modified Marshall score on Day 7 for organ failure subject (time frame: Day 7). The study lists 2 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 8 Jun 2023.