Safety and Efficacy of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis

NCT04189419 | Completed Phase 1

• 1 other identifier: APT2001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief 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, Double-blind, 2-arm, Placebo-controlled, Parallel arm for Moderate to Severe Acute Pancreatitis

Conditions

Pancreatitis, Acute

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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

  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

  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

  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)

  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

  Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28

Study Arms (2)

SCM-AGH

EXPERIMENTAL

* Ingredient: Allogeneic human bone marrow derived mesenchymal stem cells * Dose: 1x10\^6 cells/Kg

Biological: SCM-AGH

Placebo

PLACEBO COMPARATOR

IV infusion.

Other: Placebo

Interventions

SCM-AGH BIOLOGICAL

SCM-AGH will be administrated once a day for 3 days(D0, D1 and D2).

SCM-AGH

Placebo OTHER

Placebo will be administrated once a day for 3 days(D0, D1 and D2).

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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
• \- 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• SCM Lifescience Co., LTD.: lead

Study Sites (7)

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

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Yun Nah Lee

  Soon Chun Hyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: August 12, 2019
• Primary Completion: January 14, 2022
• Study Completion: March 15, 2022
• Last Updated: June 8, 2023

Record last verified: 2022-05

Locations

KR (7)