Trial Outcomes & Findings for Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis (NCT NCT02947087)

Last Updated: 2023-06-29

Results Overview

Islet graft function will be measured by 4 hour mixed meal tolerance test (MMTT) at 365 days post transplantation. Specific measurement is the C-peptide area under the curve (AUC)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

48 participants

Primary outcome timeframe

365 days

Results posted on

2023-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Prolastin-C Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks. Prolastin-C: Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation	Placebo Subjects will be given Saline weekly for 4 weeks. Placebo: Patients will receive saline on day 0, 7, 14, and 21 days of transplantation
Overall Study STARTED	32	16
Overall Study COMPLETED	29	14
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Prolastin-C Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks. Prolastin-C: Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation	Placebo Subjects will be given Saline weekly for 4 weeks. Placebo: Patients will receive saline on day 0, 7, 14, and 21 days of transplantation
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prolastin-C n=29 Participants Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks. Prolastin-C: Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation	Placebo n=14 Participants Subjects will be given Saline weekly for 4 weeks. Placebo: Patients will receive saline on day 0, 7, 14, and 21 days of transplantation	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	14 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	13 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	14 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	14 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 365 days

Population: All consented participants who received TPIAT

Islet graft function will be measured by 4 hour mixed meal tolerance test (MMTT) at 365 days post transplantation. Specific measurement is the C-peptide area under the curve (AUC)

Outcome measures

Outcome measures
Measure	Prolastin-C n=29 Participants Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks. Prolastin-C: Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation	Placebo n=14 Participants Subjects will be given Saline weekly for 4 weeks. Placebo: Patients will receive saline on day 0, 7, 14, and 21 days of transplantation
Islet Graft Function	233 ng/ml*min Standard Error 42	354 ng/ml*min Standard Error 78

Adverse Events

Prolastin-C

Serious events: 22 serious events

Other events: 15 other events

Deaths: 2 deaths

Placebo

Serious events: 8 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prolastin-C n=29 participants at risk Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks. Prolastin-C: Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation	Placebo n=14 participants at risk Subjects will be given Saline weekly for 4 weeks. Placebo: Patients will receive saline on day 0, 7, 14, and 21 days of transplantation
Gastrointestinal disorders Abdominal Pain	34.5% 10/29 • Number of events 13 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	28.6% 4/14 • Number of events 10 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders Nausea and Vomitting	10.3% 3/29 • Number of events 5 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	14.3% 2/14 • Number of events 6 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders Gastric Ulcer with or without bleeding	20.7% 6/29 • Number of events 6 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders Colitis	10.3% 3/29 • Number of events 4 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders Abdominal Fluid Collection	10.3% 3/29 • Number of events 4 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	14.3% 2/14 • Number of events 2 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Endocrine disorders Hyperglycemia	6.9% 2/29 • Number of events 2 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	14.3% 2/14 • Number of events 5 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Hepatobiliary disorders Portal Vein Thrombosis	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Infections and infestations Septic Shock	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders GI Bleeding	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.

Other adverse events

Additional Information

Hongjun Wang, PhD

MUSouthCarolina

Phone: 8437921800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Prolastin-C n=29 participants at risk Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks. Prolastin-C: Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation	Placebo n=14 participants at risk Subjects will be given Saline weekly for 4 weeks. Placebo: Patients will receive saline on day 0, 7, 14, and 21 days of transplantation
Gastrointestinal disorders Abdominal Pain	10.3% 3/29 • Number of events 11 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	21.4% 3/14 • Number of events 3 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
General disorders Fatigue	6.9% 2/29 • Number of events 3 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders Nausea and Vomitting	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 2 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Cardiac disorders Hypotension	10.3% 3/29 • Number of events 3 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Infections and infestations Cellulitis	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Immune system disorders Urticaria	0.00% 0/29 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Endocrine disorders Hyperglycemia	0.00% 0/29 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 2 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Blood and lymphatic system disorders Anemia	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Hepatobiliary disorders Portal Vein Thrombosis	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	7.1% 1/14 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Infections and infestations Urinary Tract Infection	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Nervous system disorders Seizure	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders Gastritis	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Gastrointestinal disorders Diarrhea	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Renal and urinary disorders Acute kidney injury	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Surgical and medical procedures Wound seroma	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.
Nervous system disorders Headache	3.4% 1/29 • Number of events 1 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.	0.00% 0/14 • 1 year Adverse events affecting \>3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.