DR16 DataRelease
Release Date: 12/11/2015
| SDY58: Defining signatures for immune responsiveness by functional systems immunology | |||||||||||
| Status: | New | ||||||||||
| Description: | Project 2: Immunologic and genomic signatures of response to neuroinvasive or non-neuroinvasive West Nile Virus infection. | ||||||||||
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| DOI: | 10.21430/M3Q6U5GGRT | ||||||||||
| Subjects: | 135 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY475: Characterization of the human maternal immune response 6 months or greater post delivery via cytometry Time-of-Flight(CyTOF). | |||||||
| Status: | New | ||||||
| Description: | Preterm births occur in 12 percent of pregnancies. Preterm infants are at risk for long term health problems such as impaired hearing and vision, cerebral palsy and developmental delays. This study will characterize the human maternal preterm birth immune system using Cytometry-Time-of-Flight analysis of whole blood | ||||||
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| DOI: | 10.21430/M3D8CS7ILY | ||||||
| Subjects: | 23 | ||||||
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| SDY545: GPAC ITN025AD: Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children | |||||||
| Status: | New | ||||||
| Description: | Researchers suspect that allergies to common inhaled allergens (such as house dust mite, cat dander, and grass pollens) are a major cause of childhood asthma. Recent evidence suggests that if allergies to inhaled allergens are prevented, this can cause changes in the immune system that may inhibit the development of asthma. Although strategies to prevent allergies generally focus on avoiding the allergen, complete avoidance of the common allergens linked to asthma would require extreme measures and is impractical. Oral mucosal immunoprophylaxis (OMIP) therapy is an allergy treatment that can induce long-lasting immune tolerance in people already suffering from allergies. By exposing the patient to small, repeated, but increasing doses of the problem allergen over a long period of time, the patient's immune system is eventually desensitized to that particular allergen. OMIP therapy has been shown to be safe in children as young as 2 years old. This study will evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing the development of asthma in children at high risk for developing the disease. Children enrolled in this study have been diagnosed with eczema or food allergies and have a family history of eczema, allergic rhinitis, or asthma. There are two groups in this study. The experimental arm participants will receive OMIP therapy (a mixture of house dust mite, cat, and timothy grass allergens) as daily oral drops under the tongue for 1 year; Placebo arm participants will receive an allergen free placebo solution. Participants will be followed for an additional 3 years to see whether they develop allergies or asthma and to determine how OMIP affects their immune system's response to allergens. There will be 5 study visits in the first year and 6 visits over the next 3 years. At all visits, participants will be assessed for allergy/asthma symptoms, will be asked to complete questionnaires, and may be asked to provide blood or saliva samples. | ||||||
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| DOI: | 10.21430/M3BK0YTX2J | ||||||
| Subjects: | 51 | ||||||
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| Assays: | None | ||||||
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| SDY546: FACTOR ITN507ST: Study of Tolerant Kidney Transplant Recipients | |||||||
| Status: | New | ||||||
| Description: | Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the bodys immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as immunosuppressive or anti-rejection drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to tolerate the transplanted kidney, and this condition is referred to as tolerance. In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance. Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010). | ||||||
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| DOI: | 10.21430/M3SBI9FQPC | ||||||
| Subjects: | 96 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY547: STAyCIS ITN020AI: Atorvastatin (Lipitor) Therapy in Patients with Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis | |||||||
| Status: | New | ||||||
| Description: | CIS is a single clinical event indicating temporary disruption of normal nerve function. CIS patients may have a loss of vision in one eye; trouble with balance; double vision; numbness in the face; and tingling, numbness, or weakness in the arms or legs. Some CIS patients may develop MS, but others may not. Studies have shown that when CIS is accompanied by magnetic resonance imaging (MRI)-detected brain lesions that are consistent with those seen in MS, there is a high risk of a second neurologic event and a diagnosis of MS within several years. This study will evaluate the efficacy of atorvastatin, an antihyperlipidemic, in the prevention of MS in CIS patients. This study will last 18 months. All participants must complete a 3- to 5-day course of corticosteroids at least 28 days before the baseline evaluations. This corticosteroid therapy must be initiated within 60 days of CIS onset. Participants will be randomly assigned to receive 80 mg of either atorvastatin or placebo by mouth daily for 12 months. Study visits will occur at screening and every 3 months thereafter until the end of the 18-month study. Blood collection will occur at selected visits, and other additional evaluations will be performed at Months 1 and 2. Selected participants will undergo MRI brain scans. Participants will be offered interferon beta-1a (AvonexNONASCIINONASCII), free of charge, if they develop disease activity. Participants will be instructed to report any change in their health status to their treating physician within 48 hours of the onset of symptoms. | ||||||
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| DOI: | 10.21430/M3CS60JPJJ | ||||||
| Subjects: | 83 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY549: HALT-MS ITN033AI: High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis | |||||||
| Status: | New | ||||||
| Description: | MS is a chronic autoimmune disease of the central nervous system in which myelin, the protective coat that surrounds nerve cells, is damaged or destroyed by autoimmune T cells and macrophages, leading to an eventual loss of neurologic function. In a pilot study in Europe using high-dose chemotherapy, it was observed that 18 of 19 MS patients stabilized or improved clinically, and only one patient showed a new lesion on magnetic resonance imaging (MRI) of the brain at 4.5 years after treatment. Improvement was seen in quality-of-life assessments. In ITN033AI, high-dose chemotherapy with autologous CD34-selected hematopoietic cell transplantation will be given to confirm the results from the pilot study and to offer therapy to patients with early MS and a poor prognosis. Research studies will be performed in addition to clinical assessments to better understand the effect of the treatment on the activity of MS. High-dose chemotherapy will be used to deplete autoreactive immune cells. These regimens also deplete the bone marrow, the source of blood-forming CD34+ stem cells which causes very low blood counts. Therefore, the participant's autologous CD34+ hematopoietic stem cells will be collected before high dose immunosuppressive therapy is given and then returned as a transplant post-chemotherapy. Patients will be followed closely after the autologous transplantation since they will be at risk for infections after treatment. At the beginning of the study, participants will undergo a number of screening and baseline procedures, including a physical exam, blood collection, MS-confirming neurology exams and questionnaires, and MRI procedures. Participants will be given prednisone and granulocyte-colony stimulating factor (G-CSF) to mobilize CD34+ hematopoietic stem cells from the bone marrow into the peripheral blood. When the peripheral blood CD34+ cell count reaches 20,000 cells/ml or greater, these cells will be collected by leukapheresis. In this process, a catheter is placed into a large blood vessel, peripheral blood is withdrawn, and a high speed sedimentation (leukapheresis) device is used to separate and retain the cells required for autologous transplantation. Other blood cells are then returned to the participant's body. In the laboratory, the CD34+ hematopoietic stem cell graft will be selected and prepared from the leukapheresis collection, and stored until needed for transplant. Seven or more days following the collection of their autologous graft, participants will be hospitalized and receive high-dose chemotherapy consisting of carmustine, etoposide, cytarabine, and melphalan (BEAM) and thymoglobulin. This is followed by transplantation of the autologous hematopoietic cell graft. Participants will remain in the hospital for observation during recovery of their peripheral blood cell counts, as described in the protocol. Participants will receive G-CSF and blood transfusions, if needed, and will be monitored for infections. Following discharge from the hospital, eight study visits will occur over sixty months (five years). During these visits, participants will undergo blood and urine collection, MRI studies, leukapheresis, and MS neurology exams and will complete questionnaires. | ||||||
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| DOI: | 10.21430/M3ZF1F6RNO | ||||||
| Subjects: | 25 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY660: LEAP ITN032AD: Induction of Tolerance through Early Introduction of Peanut in High-Risk Children, LEAP-On ITN049AD: The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis | |||||||
| Status: | New | ||||||
| Description: | ITN032AD: Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy.Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts.Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut.Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians. ITN049AD: This is a two-sample comparison employing all available study participants in both arms of the current LEAP study at V72. After obtaining informed consent LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into the LEAP-On Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B). At V72, after 12 months of this new intervention, all participants will have skinprick testing, specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). | ||||||
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| DOI: | 10.21430/M3SFPACKA3 | ||||||
| Subjects: | 640 | ||||||
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| Assays: | None | ||||||
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| SDY661: Khoury ITN006AI: NMS02 Safety of RG2007 (CTLA4-IgG4m) in Patients with Multiple Sclerosis | |||||||
| Status: | New | ||||||
| Description: | Safety study of subjects diagnosed with relapsing-remitting multiple sclerosis treated with escalating intravenous doses of CTLA4-IgG4m (RG2077) | ||||||
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| DOI: | 10.21430/M3YYEBXJ0L | ||||||
| Subjects: | 20 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY662: WISP-R ITN029ST: Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients | |||||||
| Status: | New | ||||||
| Description: | Immunosuppressive drugs are prescribed to organ transplant recipients to prevent organ rejection. Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from pediatric liver transplant recipents | ||||||
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| DOI: | 10.21430/M3QJJF9A71 | ||||||
| Subjects: | 25 | ||||||
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| Assays: | None | ||||||
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| SDY668: Miller-Burke ITN022ST: Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients | |||||||
| Status: | New | ||||||
| Description: | Alemtuzumab is used to treat certain blood disorders. This study evaluates kidney transplant recipients treated with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. | ||||||
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| DOI: | 10.21430/M3QZ1A9OOE | ||||||
| Subjects: | 9 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
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| SDY671: Knechtle ITN013ST: Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults | ||||||||||
| Status: | New | |||||||||
| Description: | This study will evaluate the effects of intravenous (IV) alemtuzumab and oral sirolimus and tacrolimus after kidney transplantation. The study will also evaluate this regimen's potential to allow eventual discontinuation of components of long-term immunosuppressive therapy. Study duration will be 4 years. Participants will undergo kidney transplantation on Day 0, receive IV doses of alemtuzumab, acetaminophen, and diphenhydramine on Days 0, 1, and 2, as well as methylprednisolone on Day 0. Patients will receive up to 10 days of valganciclovir or acyclovir post transplant. Daily oral doses of tacrolimus will contiue for 60 days and sirolimus daily by mouth for at least 12 months after transplant. Participants will take sulfamethoxazole-trimethoprim 3 times a week, valganciclovir or acyclovir for up to 10 days post-transplant, and clotrimazole or nystatin by mouth for at least 3 months post-transplant. Sixty-to study visits are planned to be spread out over 4 years post transplant. Sirolimus withdrawal process will occur over a minimum of 3 months at an approximate rate of 33% of the pre-withdrawal dose per month. Participants eligible for sirolimus withdrawal will undergo several kidney biopsies, including one 2 weeks prior to the start of withdrawal, 6 and 12 months after completion of withdrawal, 1 year after study enrollment, and annually thereafter. | |||||||||
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| DOI: | 10.21430/M38BB6XTX9 | |||||||||
| Subjects: | 20 | |||||||||
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| Assays: | None | |||||||||
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| SDY674: Vincenti ITN023ST: Belatacept to Prevent Organ Rejection in Kidney Transplant Patients | |||||||
| Status: | New | ||||||
| Description: | Participants, at the time of transplant, begin immunosuppressive treatment with belatacept, sirolimus and thymoglobulin. Dose reduction of belatacept begins at 12 weeks post-transplant. Drug withdrawal begins at year 2. | ||||||
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| DOI: | 10.21430/M3W336PE8D | ||||||
| Subjects: | 10 | ||||||
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| Assays: | None | ||||||
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| SDY680: Human Elispot Assay with peptide. | |||||||
| Status: | New | ||||||
| Description: | Determining CD8 T cell responses to HLA-A02 restricted Influenza A epitopes | ||||||
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| DOI: | 10.21430/M3LGJ7DDZN | ||||||
| Subjects: | 10 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY720: Age-related alterations in innate immune responses (See companion study SDY739) | |||||||||||
| Status: | New | ||||||||||
| Description: | Aging leads to dysregulation of multiple components of the immune system that result in increased susceptibility to infections and poor response to vaccines in the aging population. The dysfunctions of adaptive B and T cells are well documented but the effect of aging on innate immunity remains incompletely understood. Using a heterogeneous population of peripheral blood mononuclear cells (PBMCs), we first undertook transcriptional profiling and found that PBMCs isolated from old individuals (>= 65 yrs) exhibited a delayed and altered response to stimulation with TLR4, TLR7/8, and RIG-I agonists compared to cells obtained from adults (<= 40 yrs). This delayed response to innate immune agonists resulted in the reduced production of pro-inflammatory and antiviral cytokines and chemokines including TNFa, IL-6, IL-1b, IFNg, IFNa, CCL2 and CCL7. While the major monocyte and dendritic cell subsets did not change numerically with aging, activation of specific cell types was altered. PBMCs from old subjects also had a lower frequency of CD40+ monocytes, impaired up-regulation of PD-L1 on monocytes and T cells and increased expression of PD-L2 and B7-H4 on B cells. The defective immune response to innate agonists adversely affected adaptive immunity as TLR-stimulated PBMCs (minus CD3 T cells) from old subjects elicited significantly lower levels of adult T cell proliferation than those from adult subjects in an allogeneic mixed lymphocyte reaction (MLR). Collectively, these age-associated changes in cytokine, chemokine and interferon production, as well as co-stimulatory protein expression could contribute to the blunted memory B and T cell immune responses to vaccines and infections. | ||||||||||
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| DOI: | 10.21430/M3FZ2BAZSA | ||||||||||
| Subjects: | 61 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY736: Human Aging and CMV | |||||||
| Status: | New | ||||||
| Description: | Delineate the effect of aging from that of cytomegalovirus (CMV) infection upon relative and absolute changes in blood T cell subsets using a cohort of 391 individuals ranging in age from 21-101yrs, seperated into two subgroups based on serological CMV status. | ||||||
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| DOI: | 10.21430/M3736K8GMY | ||||||
| Subjects: | 393 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY524: AbATE ITN027AI: Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes | |||||||
| Status: | Updated | ||||||
| Description: | Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks insulin-producing beta cells in the pancreas. Without these cells, the body cannot maintain proper blood glucose levels in response to daily activities, such as eating or exercise. Generally, at the time of type 1 diabetes diagnosis, 60% to 85% of the diabetic person's beta cells have already been destroyed. However, between 15% and 40% of these cells remain and are able to produce insulin. Treatment that slows the destruction of additional beta cells may be able to decrease a patient's reliance on insulin and improve their quality of life. Anti-CD3 mAb is genetically engineered and directed against the CD3 antigen on T cells; this antibody selectively attacks the immune cells responsible for beta cell destruction. In a small exploratory clinical trial, patients with newly diagnosed type 1 diabetes who received a single, 2-week treatment with anti-CD3 mAb had preserved beta cell function and significantly lower insulin requirements than untreated patients for up to two years after therapy. This study will investigate whether a second course of anti-CD3 mAb administered one year after the first administration is able to prolong or improve the effects of the biologic in people who have recently diagnosed type 1 diabetes mellitus. Participants will be randomly assigned to one of two groups. The Experimental Group will receive anti-CD3 mAb treatment plus Diabetes Standard of Care Treatment; the Active Comparator Group will receive Diabetes Standard of Care Treatment. The Experimental Group will be treated with the antibody for the first 14 days of the study and again one year later. These participants will be admitted to the hospital for the first 5 days of a treatment cycle. Participants who live within 1 hour of the hospital may receive the remainder of a treatment cycle as an outpatient, but those who live farther away will be hospitalized for 14 days. For the first treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 1, 2, 3, 6, 9, and 12. For the second treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 13, 16, 19, 21, and 24.The Active Comparator Group will have 12 study visits over two years. At study entry, all participants will receive daily iron supplementation, either as ferrous sulfate or a multivitamin with iron. Participants will be followed for up to 2 years to assess their overall diabetes health and to capture laboratory measures of beta cell and immune system function. Medication history and adverse event assessment will occur at all visits. A physical exam, vital signs measurement, and blood collection will occur at most visits. Medical history and urine collection will occur at selected visits. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3YQ7O1CPL | ||||||
| Subjects: | 83 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY565: IL2-RAPA ITN018AI: Proleukin and Rapamune in Type 1 Diabetes Mellitus | |||||||
| Status: | Updated | ||||||
| Description: | At the time of diagnosis, type 1 diabetes patients have 15-40 percent of their beta cells may remain active and healthy in the pancreas. This Phase I study for individuals 18-45 years of age and diagnosed with type 1 diabetes in the past 3-48 months will be treated with Proleukin (subcutaneously) 3 times per week for 28 days and Rapamune (orally, daily) for 12 weeks. The trial will test whether the combination of Proleukin and Rapamune can be safely administered and whether treatment halts the autoimmune destruction of remaining beta cells. | ||||||
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| DOI: | 10.21430/M3CRD72E92 | ||||||
| Subjects: | 9 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY567: Shapiro ITN005CT: Islet Transplantation in Type 1 Diabetic Patients | |||||||
| Status: | Updated | ||||||
| Description: | The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression. | ||||||
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| DOI: | 10.21430/M3V0RG6S52 | ||||||
| Subjects: | 34 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY568: Orban ITN012AI: Evaluation of Diabetes Vaccine IBC-VSO1 in Newly Diagnosed Diabetics | |||||||
| Status: | Updated | ||||||
| Description: | This study will evaluate whether IBC-VSO1 vaccine, a synthetic metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction, protects against autoimmune attack in newly diagnosed type 1 diabetes patients. Halting beta-cell destruction may result in a prolonged remission and subsequent delay in diabetes related complications. Patients in this study must have been diagnosed with type 1 diabetes no more than 3 months prior to study enrollment. | ||||||
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| DOI: | 10.21430/M3IBWCGI97 | ||||||
| Subjects: | 12 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY569: Herold II ITN007AI: Treatment with hOKT3-gamma-1 (Ala-Ala) in Type 1 Diabetes Mellitus | |||||||
| Status: | Updated | ||||||
| Description: | This open-label phase II trial involving 2 arms where treatment is 0 or 3 cycles of hOKT3gamma1 (Ala-Ala) 6 months apart over the first year of disease in participants with new onset T1DM. Cycles consist of 12 daily doses hOKT3gamma1 (Ala-Ala). | ||||||
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| DOI: | 10.21430/M3WGK6K01J | ||||||
| Subjects: | 11 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||