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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05973734
Other study ID # 58350
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date October 1, 2023
Est. completion date May 2028

Study information

Verified date August 2023
Source Stanford University
Contact Kevin Ly, BS
Phone 650-497-6057
Email kevinly@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn if patients who have brittle type 1 diabetes receiving an islet transplantation will have better control of their sugars if they also receive one of 2 types of immune cells along with the islet transplant. The participants will receive either their own immune cells, called regulatory T cells, or immune cells from the bone marrow of the islet donor.


Description:

Islet transplantation success remains limited by the immediate loss of islet after transplantation, rejection, and side effect from immunosuppression. Preclinical animal models provide evidence that donor bone marrow cells OR regulatory T cells infused at the time of islet transplantation can improve the survival of islets after transplantation and reduce the need for immunosuppression. The purpose of this study is to evaluate the feasibility and safety of combining an islet transplant with the recipient's Tregs OR deceased donor bone marrow cells in patients with brittle type 1 diabetes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date May 2028
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Male and female patients age 18 to 70 years of age. - Ability to provide written informed consent. - Mentally stable and able to comply with the procedures of the study protocol. - Clinical history compatible with T1D with onset of disease at < 45 years of age, insulin- dependence for = 5 years at the time of enrollment, or a sum of patient age and insulin dependent diabetes duration of = 28. - Absence of stimulated C peptide (< 0.3 ng/mL) in response to a mixed meal tolerance test measured at 60 and 90 minutes after the start of consumption - Involvement in intensive diabetes management defined as self-monitoring of glucose values no less than a mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or insulin pump therapy. Such management must be under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least 3 clinical evaluations during the 12 months prior to study enrollment. - At least two episodes of severe hypoglycemia in the 12 months prior to study enrollment. - Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR a HYPO score greater than or equal to the 90th percentile (1047) during the screening period and within the last 6 months prior to randomization. - Women of childbearing potential may be enrolled if a pregnancy test is negative, and they agree to the use of 2 forms of contraception from Screening to the end of the study. Males must agree to use 2 forms of contraception from Screening to the end of the study if their partners are of childbearing potential. - Acceptable methods of birth control which must be used together are: - Oral contraceptive and condom (combination oral contraceptives containing the second- generation progestin (levonorgestrel) and <30 µg of estrogen should be utilized), - IUD and condom, - Diaphragm with spermicide and condom - Subject must complete training on how to use the Tandem X2 pump with Control IQ technology by a certified Diabetes Educator or physician. Patients must complete at least 2 hour training to the satisfaction of the educator and show proficiency and understanding in its use as judged by the educator. - Patients with prior kidney transplantation on immunosuppressive medications are eligible provided they meet all eligibility criteria above excluding the need for hypoglycemia unawareness. Patients should not be candidates for solid organ pancreas transplant or have declined the surgical option. - Exclusion Criteria: - Body mass index (BMI) >30 kg/m2 or patient weight =50kg. - Insulin requirement of >1.0 IU/kg/day or <15 U/day. 3. HbA1c >10%. - Treatment with any anti-diabetic medication other than insulin within 4 weeks of Screening - Untreated proliferative diabetic retinopathy. - Blood Pressure: SBP >180 mmHg or DBP >100 mmHg on optimal treatment. - Estimated glomerular filtration rate of <50 mL/min/1.73m2. - Presence or history of macroalbuminuria (>500mg/g creatinine). - Presence or history of panel-reactive anti-HLA antibodies >50%. Negative cross- match by flow cytometry and no DSA to organ donor by standard methods. - For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male participants: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception - Presence of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection. - Negative screen for Epstein-Barr Virus (EBV) by IgG determination. - Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment. - Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin. - Known active alcohol or substance abuse. - Baseline Hb below the lower limits of normal; neutropenia (<1,500/7L), or thrombocytopenia (platelets <100,000/7L). - Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after islet transplantation (low-dose aspirin treatment is allowed) or patients with an international normalized ratio (INR) >1.5. - Severe co-existing cardiac disease, characterized by any one of these conditions: - recent myocardial infarction (within past 6 months). - evidence of uncorrectable ischemia on functional cardiac exam within the last year. - left ventricular ejection fraction <30%. - Persistent elevation of liver function tests at the time of study entry. Persistent serum glutamic-oxaloacetic transaminase (SGOT [AST]), serum glutamate pyruvate transaminase (SGPT [ALT]), or total bilirubin, with values > 1.5 times normal upper limits will exclude a patient. - Acute or chronic pancreatitis. - Treatment with any anti-diabetic medication other than insulin within 4 weeks of enrollment. - Use of any investigational agents within 4 or more weeks of enrollment, depending upon the pharmacokinetics of the investigational agent and durability of changes with treatment in immune function or glycemic regulation. - Administration of live attenuated vaccine(s) within 2 months of enrollment. - Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial. - A previous islet transplant. - History of medical non-adherence or poor social support. - Individuals with selective IgA deficiencies (IgA level less than 15 mg/dL) who have known antibody against IgA.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Infusion of recipient T regulatory cell
Patients will undergo a single apheresis collection with a target total blood volume of 20-30 L and the collected cells used as the source of purified Tregs to be infused following the islet transplantation. In the event a patient is unable to meet the collection target, a second collection may be performed.
Infusion of concomitant Donor Derived Vertebral Bone Marrow
The cells from the donor VB and spleen are processed under cGMP conditions and released for infusion after the respective recipient has undergone transplant and conditioning. Under this protocol, the donor's VB will be obtained at the same time as the pancreatic islets and will be the source of HSC for infusion with the intent to establish immune tolerance to the donor's pancreatic islet cells. Subjects will receive one infusion of allogeneic cadaveric islets. Subjects will receive induction therapy with ATG and Belatacept and maintenance immunosuppression with Tacrolimus Extended-release tablets (Envarsus XR) and Mycophenolate Mofetil (MMF). After islet transplantation, the VBM cells will be infused in one time window: on day 0-1. Subjects will undergo closed-loop insulin pump glucose control peri-transplant.

Locations

Country Name City State
United States Stanford University Palo Alto California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (44)

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Hirshberg B, Rother KI, Digon BJ 3rd, Lee J, Gaglia JL, Hines K, Read EJ, Chang R, Wood BJ, Harlan DM. Benefits and risks of solitary islet transplantation for type 1 diabetes using steroid-sparing immunosuppression: the National Institutes of Health experience. Diabetes Care. 2003 Dec;26(12):3288-95. doi: 10.2337/diacare.26.12.3288. — View Citation

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Huber BC, Ransohoff JD, Ransohoff KJ, Riegler J, Ebert A, Kodo K, Gong Y, Sanchez-Freire V, Dey D, Kooreman NG, Diecke S, Zhang WY, Odegaard J, Hu S, Gold JD, Robbins RC, Wu JC. Costimulation-adhesion blockade is superior to cyclosporine A and prednisone immunosuppressive therapy for preventing rejection of differentiated human embryonic stem cells following transplantation. Stem Cells. 2013 Nov;31(11):2354-63. doi: 10.1002/stem.1501. — View Citation

Kessler L, Passemard R, Oberholzer J, Benhamou PY, Bucher P, Toso C, Meyer P, Penfornis A, Badet L, Wolf P, Colin C, Morel P, Pinget M; GRAGIL Group. Reduction of blood glucose variability in type 1 diabetic patients treated by pancreatic islet transplantation: interest of continuous glucose monitoring. Diabetes Care. 2002 Dec;25(12):2256-62. doi: 10.2337/diacare.25.12.2256. — View Citation

Koulmanda M, Bhasin M, Fan Z, Hanidziar D, Goel N, Putheti P, Movahedi B, Libermann TA, Strom TB. Alpha 1-antitrypsin reduces inflammation and enhances mouse pancreatic islet transplant survival. Proc Natl Acad Sci U S A. 2012 Sep 18;109(38):15443-8. doi: 10.1073/pnas.1018366109. Epub 2012 Sep 4. — View Citation

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Lloveras J, Farney AC, Sutherland DE, Wahoff D, Field J, Gores PF. Significance of contaminated islet preparations in clinical islet transplantation. Transplant Proc. 1994 Apr;26(2):579-80. No abstract available. — View Citation

Manciu N, Beebe DS, Tran P, Gruessner R, Sutherland DE, Belani KG. Total pancreatectomy with islet cell autotransplantation: anesthetic implications. J Clin Anesth. 1999 Nov;11(7):576-82. doi: 10.1016/s0952-8180(99)00100-2. — View Citation

Mao Q, Terasaki PI, Cai J, Briley K, Catrou P, Haisch C, Rebellato L. Extremely high association between appearance of HLA antibodies and failure of kidney grafts in a five-year longitudinal study. Am J Transplant. 2007 Apr;7(4):864-71. doi: 10.1111/j.1600-6143.2006.01711.x. — View Citation

Markmann JF, Deng S, Huang X, Desai NM, Velidedeoglu EH, Lui C, Frank A, Markmann E, Palanjian M, Brayman K, Wolf B, Bell E, Vitamaniuk M, Doliba N, Matschinsky F, Barker CF, Naji A. Insulin independence following isolated islet transplantation and single islet infusions. Ann Surg. 2003 Jun;237(6):741-9; discussion 749-50. doi: 10.1097/01.SLA.0000072110.93780.52. — View Citation

Mehigan DG, Bell WR, Zuidema GD, Eggleston JC, Cameron JL. Disseminated intravascular coagulation and portal hypertension following pancreatic islet autotransplantation. Ann Surg. 1980 Mar;191(3):287-93. doi: 10.1097/00000658-198003000-00006. — View Citation

Meyer EH, Laport G, Xie BJ, MacDonald K, Heydari K, Sahaf B, Tang SW, Baker J, Armstrong R, Tate K, Tadisco C, Arai S, Johnston L, Lowsky R, Muffly L, Rezvani AR, Shizuru J, Weng WK, Sheehan K, Miklos D, Negrin RS. Transplantation of donor grafts with defined ratio of conventional and regulatory T cells in HLA-matched recipients. JCI Insight. 2019 May 16;4(10):e127244. doi: 10.1172/jci.insight.127244. eCollection 2019 May 16. — View Citation

Mittal VK, Toledo-Pereyra LH, Sharma M, Ramaswamy K, Puri VK, Cortez JA, Gordon D. Acute portal hypertension and disseminated intravascular coagulation following pancreatic islet autotransplantation after subtotal pancreatectomy. Transplantation. 1981 Apr;31(4):302-4. No abstract available. — View Citation

Olack BJ, Swanson CJ, Flavin KS, Phelan D, Brennan DC, White NH, Lacy PE, Scharp DW, Poindexter N, Mohanakumar T. Sensitization to HLA antigens in islet recipients with failing transplants. Transplant Proc. 1997 Jun;29(4):2268-9. doi: 10.1016/s0041-1345(97)00327-8. No abstract available. — View Citation

Pierini A, Iliopoulou BP, Peiris H, Perez-Cruz M, Baker J, Hsu K, Gu X, Zheng PP, Erkers T, Tang SW, Strober W, Alvarez M, Ring A, Velardi A, Negrin RS, Kim SK, Meyer EH. T cells expressing chimeric antigen receptor promote immune tolerance. JCI Insight. 2017 Oct 19;2(20):e92865. doi: 10.1172/jci.insight.92865. — View Citation

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Rickels MR, Kamoun M, Kearns J, Markmann JF, Naji A. Evidence for allograft rejection in an islet transplant recipient and effect on beta-cell secretory capacity. J Clin Endocrinol Metab. 2007 Jul;92(7):2410-4. doi: 10.1210/jc.2007-0172. Epub 2007 May 8. — View Citation

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Ryan EA, Shandro T, Green K, Paty BW, Senior PA, Bigam D, Shapiro AM, Vantyghem MC. Assessment of the severity of hypoglycemia and glycemic lability in type 1 diabetic subjects undergoing islet transplantation. Diabetes. 2004 Apr;53(4):955-62. doi: 10.2337/diabetes.53.4.955. — View Citation

Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401. — View Citation

Streja D. Can continuous glucose monitoring provide objective documentation of hypoglycemia unawareness? Endocr Pract. 2005 Mar-Apr;11(2):83-90. doi: 10.4158/EP.11.2.83. — View Citation

Taylor GD, Kirkland T, Lakey J, Rajotte R, Warnock GL. Bacteremia due to transplantation of contaminated cryopreserved pancreatic islets. Cell Transplant. 1994 Jan-Feb;3(1):103-6. doi: 10.1177/096368979400300114. — View Citation

Terasaki PI, Ozawa M, Castro R. Four-year follow-up of a prospective trial of HLA and MICA antibodies on kidney graft survival. Am J Transplant. 2007 Feb;7(2):408-15. doi: 10.1111/j.1600-6143.2006.01644.x. Epub 2007 Jan 4. — View Citation

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* Note: There are 44 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of Grade 3 to 5 cytokine release syndrome / acute infusion reaction after Treg administration infusion reaction after Treg administration Grade 3 to 5 cytokine release syndrome / acute infusion reaction after Treg administration infusion reaction after Treg administration within 3 months
Primary Occurrence of grade 4 or greater adverse events of islet transplantation Adverse event grade 4 or greater Within two years
Primary Number of patients who receive Treg infusions (Arm1) or Donor Derived Vertebral Bone Marrow (Arm2) and islet transplantation (feasibility) Number of patients who received planned Treg or Donor Bone Marrow Within two years
Secondary HbA1c =6.5% HbA1c =6.5% assessed at 6, 12 and 24 months post-islet transplantation
Secondary Absence of severe hypoglycemic events Absence of severe hypoglycemic event , requiring intervention by other person than the patient assessed at 6, 12 and 24 months post-islet transplantation
Secondary Decrease of insulin mean requirements (u/kg) from prior to transplantation by 50% of total daily dose Reduction of exogenous insulin requirement by 50% from baseline assessed at 6, 12 and 24 months post-islet transplantation
Secondary Clarke hypoglycemia severity (HYPO) score less than 2 (0 to >4, >4 indicate severe hypoglycemia unawareness) Improvement of Clarke score to less than 2 assessed at 6, 12 and 24 months post-islet transplantation
Secondary Basal C-peptide at levels e >0.5 ng/mL (>0.17 nmol/L) fasting or stimulated. C-petide production from islet transplant assessment assessed at 6, 12 and 24 months post-islet transplantation
Secondary Target of glucose variability and hypoglycemia duration derived from the CGMS <Standard Deviation and Coefficient targets> Monitoring of glucose control 24h sensor monitoring assessed at 6, 12 and 24 months post-islet transplantation
Secondary Measurement of donor Specific Antibody, cPRA Single bead luminex anti HLA class 1 and 2 assay assessed at 6, 12 and 24 months post-islet transplantation
Secondary Quality of life (QOL) assessment QOL questionnaire SF-12 (0-100, higher score is better outcome) assessed at 6, 12 and 24 months post-islet transplantation
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