Abstract

This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This project is a pilot study to investigate the safety, efficacy and the immunologic mechanisms of insulin B-chain in incomplete Freund's adjuvant (IFA) in humans to prevent or delay further loss of beta cell mass after the clinical onset of Type 1 diabetes mellitus. Immunization with autoantigens in different autoimmune diseases appear to be a new, effective approach to treatment in humans and animals alike. Six subjects were given a single injection of IBC-VS01 and six subjects were given a single injection of the fluid part of IBC-VS01 without the piece of insulin mixed in it. Without the piece of insulin, this injection called (VSO2) is expected to have no effect. After the injection the 12 subjects are followed for two years to see what effects IBC-VS01 and VSO2 have on the course of diabetes and whether IBC-VS01 has any ill effects in subjects compared to VS02.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001032-32
Application #
7606985
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-04-01
Project End
2008-03-31
Budget Start
2007-04-01
Budget End
2008-03-31
Support Year
32
Fiscal Year
2007
Total Cost
$7,631
Indirect Cost

  Institution

Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code

  Publications

Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Chung, Chen-Chih; Pimentel Maldonado, Daniela A; Jor'dan, Azizah J et al. (2018) Lower cerebral vasoreactivity as a predictor of gait speed decline in type 2 diabetes mellitus. J Neurol 265:2267-2276
Kline, Emily R; Seidman, Larry J; Cornblatt, Barbara A et al. (2018) Depression and clinical high-risk states: Baseline presentation of depressed vs. non-depressed participants in the NAPLS-2 cohort. Schizophr Res 192:357-363
Simpson, Norah S; Scott-Sutherland, Jennifer; Gautam, Shiva et al. (2018) Chronic exposure to insufficient sleep alters processes of pain habituation and sensitization. Pain 159:33-40
Dai, Weiying; Duan, Wenna; Alfaro, Freddy J et al. (2017) The resting perfusion pattern associates with functional decline in type 2 diabetes. Neurobiol Aging 60:192-202
Brosnahan, Godela M; Abebe, Kaleab Z; Rahbari-Oskoui, Frederic F et al. (2017) Effect of Statin Therapy on the Progression of Autosomal Dominant Polycystic Kidney Disease. A Secondary Analysis of the HALT PKD Trials. Curr Hypertens Rev 13:109-120
Torres, Vicente E; Abebe, Kaleab Z; Schrier, Robert W et al. (2017) Dietary salt restriction is beneficial to the management of autosomal dominant polycystic kidney disease. Kidney Int 91:493-500
Irazabal, María V; Abebe, Kaleab Z; Bae, Kyongtae Ty et al. (2017) Prognostic enrichment design in clinical trials for autosomal dominant polycystic kidney disease: the HALT-PKD clinical trial. Nephrol Dial Transplant 32:1857-1865
Seidman, Larry J; Shapiro, Daniel I; Stone, William S et al. (2016) Association of Neurocognition With Transition to Psychosis: Baseline Functioning in the Second Phase of the North American Prodrome Longitudinal Study. JAMA Psychiatry 73:1239-1248
Thermenos, Heidi W; Juelich, Richard J; DiChiara, Samantha R et al. (2016) Hyperactivity of caudate, parahippocampal, and prefrontal regions during working memory in never-medicated persons at clinical high-risk for psychosis. Schizophr Res 173:1-12

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