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Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT

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ClinicalTrials.gov Identifier: NCT05095532
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : March 25, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Hongjun Wang, Medical University of South Carolina

Brief Summary:
This is a clinical trial for non-diabetic chronic pancreatitis (CP) patients undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomized to either bone marrow-derived mesenchymal stem cells (MSCs) or control with the standard of care. Participants will be followed for one-year post-transplant.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Mesenchymal Stem Cells Biological: Bone marrow-derived mesenchymal stem cells Other: Placebo Phase 1

Detailed Description:
This will be a randomized, controlled clinical trial for CP patients scheduled to undergo a TP-IAT surgery. Those who are consented will be randomized into one of three groups. One group will receive islet transplantation alone, a placebo. The other two groups will receive islets plus autologous bone marrow-MSCs at two different doses (20x10^6/patient, or 50x10^6/patient). The TP-IAT procedure will remain as routinely performed. Patients will be followed for12 months post-transplantation, having 3 follow-up visits scheduled on days 90, 180, and 365 after the transplant. The primary endpoint will be a change in islet function from baseline to 12 months post-transplantation as measured by the C-peptide area under the curve following a mixed meal tolerance test. Potential effects of MSCs on glycemic control, pain relief, quality of life, and adverse events will be evaluated at each follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a randomized, controlled clinical trial in which non-diabetic CP patients scheduled for TP-IAT who meet the study criteria and consented will be randomized into three groups. One group will receive islet transplantation alone (n=14). The other two groups will receive islets plus BM-MSCs at two different doses (20x10^6/patient, or 50x10^6/patient, n=14 in each group).
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: BM-MSCs at 20x10^6
One time infusion of islets plus BM-MSCs at 20x10^6/patient, n=14
Biological: Bone marrow-derived mesenchymal stem cells
MSC transplantation

Experimental: BM-MSCs at 50x10^6
One time infusion of islets plus BM-MSCs at 50x10^6/patient, n=14
Biological: Bone marrow-derived mesenchymal stem cells
MSC transplantation

Placebo Comparator: Placebo
One time infusion of islets only.
Other: Placebo
Standard of Care




Primary Outcome Measures :
  1. Change in Islet Cell Function [ Time Frame: 1 year ]
    The primary endpoint will be change in islet function between baseline and 12 months as measured by area under the curve of C-peptide levels during a mixed meal tolerance test (MMTT) adjusted by islet equivalent number (IEQ) transplanted.


Secondary Outcome Measures :
  1. Change in HbA1C levels from baseline to 12 months. [ Time Frame: 1 year ]
    Change in HbA1C levels from baseline to 12 months

  2. Proportion of insulin-independent patients following IAT [ Time Frame: 1 year ]
    Proportion of insulin-independent patients following IAT

  3. Average daily insulin requirement [ Time Frame: 1 year ]
    Average daily insulin requirement

  4. Beta cell function as assessed by beta-score [ Time Frame: 1 year ]
    β-score is an assessment of beta cell function after islet transplantation incorporating fasting plasma glucose levels, HbA1c, daily insulin, and stimulated c-peptide. The range of the score is from 0 to 8. Higher number means better beta cell transplant function.


Other Outcome Measures:
  1. Change in islet function between baseline to day 90±28 [ Time Frame: 90 days ]
    Change in islet function between baseline to day 90±28. Islet function will be indicated by area under the curve of C-peptide levels during a mixed meal tolerance test adjusted by islet equivalent number transplanted.

  2. Daily oral Morphine Equivalents on day prior to visit [ Time Frame: 9 months ]
    Daily oral Morphine Equivalents on day prior to visit (day 90±28 to day 365±28)

  3. Proportion of patients remaining on narcotics [ Time Frame: 9 months ]
    Proportion of patients remaining on narcotics (day 90±28 to day 365±28).

  4. Short form (SF)-12 Quality of Life score [ Time Frame: 1 year ]
    SF-12 Quality of Life score, Scores range from 0 to100, with higher scores indicating better physical and mental healthy functioning.

  5. Glycemic control measured by area under the curve (AUC) HbA1c through year 1 and the C-peptide AUC and HbA1c AUC through year 1 (measured every three months) as impacted in a multivariate model by the IEQ/kg islets transplanted. [ Time Frame: 1 year ]
    Glycemic control measured by area under the curve (AUC) HbA1c through year 1 and the C-peptide AUC and HbA1c AUC through year 1 (measured every three months) as impacted in a multivariate model by the IEQ/kg islets transplanted.

  6. Incidence and severity of adverse events and serious adverse events [ Time Frame: 1 year ]
    Incidence and severity of adverse events and serious adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CP and scheduled for TP-IAT;
  • ≥18 years old;
  • Diabetes-free before surgery as defined by the standards of the American Diabetes Association*.
  • No previous major pancreatic surgeries. Patients who have had minor surgeries including transduodenal sphincteroplasty or Whipple/Beger procedure are eligible.

Exclusion Criteria:

  • Patients who are under immunosuppression;
  • Pregnant and breastfeeding women.
  • Patients who have liver damage based on ALT, AST, and total bilirubin levels (>3 times normal levels);
  • Patients who have had prior pancreatic surgeries including distal pancreatectomy or lateral pancreaticojejunostomy. We have observed that islet yield and function are negatively correlated with these types of pancreatic surgeries.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05095532


Contacts
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Contact: Susan Norton 843-792-6280 nortons@musc.edu
Contact: Kelsey Cook 843 876 0420 conder@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Meghan Blalock    843-792-2813    schneidm@musc.edu   
Contact: Me         
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Director: Charlton Strange, M.D Medical University of South Carolina
Study Director: Katherine Morgan, M.D Medical University of South Carolina
Principal Investigator: Hongjun Wang Medical University of South Carolina
Publications:

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Responsible Party: Hongjun Wang, Professor, Scientific Director, Center for Cellular Therapy, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05095532    
Other Study ID Numbers: Pro00099487
R01DK126454 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongjun Wang, Medical University of South Carolina:
Total Pancreatectomy
TP-IAT
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases