Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT05095532
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2021-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a randomized, controlled clinical trial in which 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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in islet function between baseline to day 90±28', 'timeFrame': '90 days', 'description': '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.'}, {'measure': 'Daily oral Morphine Equivalents on day prior to visit', 'timeFrame': '9 months', 'description': 'Daily oral Morphine Equivalents on day prior to visit (day 90±28 to day 365±28)'}, {'measure': 'Proportion of patients remaining on narcotics', 'timeFrame': '9 months', 'description': 'Proportion of patients remaining on narcotics (day 90±28 to day 365±28).'}, {'measure': 'Short form (SF)-12 Quality of Life score', 'timeFrame': '1 year', 'description': 'SF-12 Quality of Life score, Scores range from 0 to100, with higher scores indicating better physical and mental healthy functioning.'}, {'measure': '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.', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Incidence and severity of adverse events and serious adverse events', 'timeFrame': '1 year', 'description': 'Incidence and severity of adverse events and serious adverse events'}], 'primaryOutcomes': [{'measure': 'Change in Islet Cell Function', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1C levels from baseline to 12 months.', 'timeFrame': '1 year', 'description': 'Change in HbA1C levels from baseline to 12 months'}, {'measure': 'Proportion of insulin-independent patients following IAT', 'timeFrame': '1 year', 'description': 'Proportion of insulin-independent patients following IAT'}, {'measure': 'Average daily insulin requirement', 'timeFrame': '1 year', 'description': 'Average daily insulin requirement'}, {'measure': 'Beta cell function as assessed by beta-score', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Pancreatectomy', 'TP-IAT'], 'conditions': ['Chronic Pancreatitis', 'Mesenchymal Stem Cells']}, 'referencesModule': {'references': [{'pmid': '19104425', 'type': 'BACKGROUND', 'citation': 'Sutherland DE, Gruessner AC, Carlson AM, Blondet JJ, Balamurugan AN, Reigstad KF, Beilman GJ, Bellin MD, Hering BJ. Islet autotransplant outcomes after total pancreatectomy: a contrast to islet allograft outcomes. Transplantation. 2008 Dec 27;86(12):1799-802. doi: 10.1097/TP.0b013e31819143ec.'}, {'pmid': '29289751', 'type': 'BACKGROUND', 'citation': 'Morgan KA, Lancaster WP, Owczarski SM, Wang H, Borckardt J, Adams DB. Patient Selection for Total Pancreatectomy with Islet Autotransplantation in the Surgical Management of Chronic Pancreatitis. J Am Coll Surg. 2018 Apr;226(4):446-451. doi: 10.1016/j.jamcollsurg.2017.12.018. Epub 2017 Dec 28.'}, {'pmid': '30680957', 'type': 'BACKGROUND', 'citation': 'Wang J, Zhang Y, Cloud C, Duke T, Owczarski S, Mehrotra S, Adams DB, Morgan K, Gilkeson G, Wang H. Mesenchymal Stem Cells from Chronic Pancreatitis Patients Show Comparable Potency Compared to Cells from Healthy Donors. Stem Cells Transl Med. 2019 May;8(5):418-429. doi: 10.1002/sctm.18-0093. Epub 2019 Jan 24.'}, {'pmid': '28854965', 'type': 'BACKGROUND', 'citation': 'Song L, Sun Z, Kim DS, Gou W, Strange C, Dong H, Cui W, Gilkeson G, Morgan KA, Adams DB, Wang H. Adipose stem cells from chronic pancreatitis patients improve mouse and human islet survival and function. Stem Cell Res Ther. 2017 Aug 30;8(1):192. doi: 10.1186/s13287-017-0627-x.'}, {'pmid': '15677790', 'type': 'BACKGROUND', 'citation': 'Ryan EA, Paty BW, Senior PA, Lakey JR, Bigam D, Shapiro AM. Beta-score: an assessment of beta-cell function after islet transplantation. Diabetes Care. 2005 Feb;28(2):343-7. doi: 10.2337/diacare.28.2.343.'}, {'pmid': '23411743', 'type': 'BACKGROUND', 'citation': 'Wang H, Desai KD, Dong H, Owzarski S, Romagnuolo J, Morgan KA, Adams DB. Prior surgery determines islet yield and insulin requirement in patients with chronic pancreatitis. Transplantation. 2013 Apr 27;95(8):1051-7. doi: 10.1097/TP.0b013e3182845fbb.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical trial for 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CP and scheduled for TP-IAT;\n* ≥18 years old;\n* Diabetes with HbA1c \\<12%.\n\nExclusion Criteria:\n\n* Patients who are under immunosuppression;\n* Pregnant and breastfeeding women.\n* Patients who have liver damage based on ALT, AST, and total bilirubin levels (\\>3 times normal levels);'}, 'identificationModule': {'nctId': 'NCT05095532', 'briefTitle': 'Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation', 'orgStudyIdInfo': {'id': 'Pro00099487'}, 'secondaryIdInfos': [{'id': 'R01DK126454', 'link': 'https://reporter.nih.gov/quickSearch/R01DK126454', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BM-MSCs at 20x10^6', 'description': 'One time infusion of islets plus BM-MSCs at 20x10\\^6/patient, n=14', 'interventionNames': ['Biological: Bone marrow-derived mesenchymal stem cells']}, {'type': 'EXPERIMENTAL', 'label': 'BM-MSCs at 50x10^6', 'description': 'One time infusion of islets plus BM-MSCs at 50x10\\^6/patient, n=14', 'interventionNames': ['Biological: Bone marrow-derived mesenchymal stem cells']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One time infusion of islets only.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Bone marrow-derived mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'MSC transplantation', 'armGroupLabels': ['BM-MSCs at 20x10^6', 'BM-MSCs at 50x10^6']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Standard of Care', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leah Benn, MPH', 'role': 'CONTACT', 'email': 'bennle@musc.edu', 'phone': '843-792-2813'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Leah Benn, MPH', 'role': 'CONTACT', 'email': 'bennle@musc.edu', 'phone': '843-792-2813'}, {'name': 'Kelsey Cook', 'role': 'CONTACT', 'email': 'conder@musc.edu', 'phone': '843 876 0420'}], 'overallOfficials': [{'name': 'Charlton Strange, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'William Lancaster, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Hongjun Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Scientific Director, Center for Cellular Therapy', 'investigatorFullName': 'Hongjun Wang', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}