NCT02384018

Brief Summary

The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently, the investigators intend to test whether infusion of MSCs immediately after islet autograft can reduce onset of diabetes and improve glycemic control after total pancreatectomy and islet autotransplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2017

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

December 16, 2014

Last Update Submit

March 23, 2022

Conditions

Chronic PancreatitisDiabetes

Outcome Measures

Primary Outcomes (1)

  • C-peptide level after mixed meal tolerance test

    12 months

Secondary Outcomes (2)

  • Liver function, kidney function

    12 months after transplant

  • The absence of severe hypoglycemic episodes

    12 months after transplant

Study Arms (2)

Control

NO INTERVENTION

Patients will receive standard islet transplantation.

autologous mesenchymal stromal cell

EXPERIMENTAL

Patients will receive MSCs together with standard islet transplantation.

Biological: autologous mesenchymal stromal cell

Interventions

autologous mesenchymal stromal cellBIOLOGICAL

Islet transplantation patients will receive autologous MSCs following islets infusion

autologous mesenchymal stromal cell

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pancreatitis patients who undergo TP-IAT.
  • \>18 years of age.
  • Patients with BMI from 18.5 to 30.
  • Renal function: \>90mls/min/1.73m squared
  • Normal INR/PT/PTT values for MUSC clinical laboratory standards
  • Diabetes free before surgery (fasting blood glucose\<125mg/dl).
  • No prior pancreatic surgery with the exception of transduodenal sphincteroplasty or Whipple/Beger procedure.
  • Patients with normal liver function as measured by serum levels of aminotransferase including alanine aminotransferase (ALT), and aspartate aminotransferase (AST), and total bilirubin levels.

You may not qualify if:

  • Patients whose Hemoglobin, Hematocrit, and Platelet count are above or below normal values for MUSC clinical laboratory standards.
  • Patients who has hematological malignancy.
  • Patients who are under immunosuppression.
  • Patients with marked calcification disease on CT scan.
  • Patients with severe fibrosis and atrophy on pancreas MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GI Surgery, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Wang H, Strange C, Nietert PJ, Wang J, Turnbull TL, Cloud C, Owczarski S, Shuford B, Duke T, Gilkeson G, Luttrell L, Hermayer K, Fernandes J, Adams DB, Morgan KA. Autologous Mesenchymal Stem Cell and Islet Cotransplantation: Safety and Efficacy. Stem Cells Transl Med. 2018 Jan;7(1):11-19. doi: 10.1002/sctm.17-0139. Epub 2017 Nov 21.

    PMID: 29159905RESULT

MeSH Terms

Conditions

Pancreatitis, ChronicDiabetes Mellitus

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hongjun Wang, Ph.D

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 16, 2014

First Posted

March 10, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

November 21, 2017

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

US(1)