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- Blenckner, Thorsten, et al.
(author)
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The Baltic Health Index (BHI): Assessing the social-ecological status of the Baltic Sea
- 2021
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In: People and Nature. - : Wiley. - 2575-8314. ; 3:2, s. 359-375
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Journal article (peer-reviewed)abstract
- Improving the health of coastal and open sea marine ecosystems represents a substantial challenge for sustainable marine resource management, since it requires balancing human benefits and impacts on the ocean. This challenge is often exacerbated by incomplete knowledge and lack of tools that measure ocean and coastal ecosystem health in a way that allows consistent monitoring of progress towards predefined management targets. The lack of such tools often limits capabilities to enact and enforce effective governance. We introduce the Baltic Health Index (BHI) as a transparent, collaborative and repeatable assessment tool. The Index complements existing, more ecological-oriented, approaches by including a human dimension on the status of the Baltic Sea, an ecosystem impacted by multiple anthropogenic pressures and governed by a multitude of comprehensive national and international policies. Using a large amount of social-ecological data available, we assessed the health of the Baltic Sea for nine goals that represent the status towards set targets, for example, clean waters, biodiversity, food provision, natural products extraction and tourism. Our results indicate that the overall health of the Baltic Sea is suboptimal (a score of 76 out of 100), and a substantial effort is required to reach the management objectives and associated targets. Subregionally, the lowest BHI scores were measured for carbon storage, contaminants and lasting special places (i.e. marine protected areas), albeit with large spatial variation. Overall, the likely future status of all goals in the BHI averaged for the entire Baltic Sea is better than the present status, indicating a positive trend towards a healthier Baltic Sea. However, in some Baltic Sea basins, the trend for specific goals was decreasing, highlighting locations and issues that should be the focus of management priorities. The BHI outcomes can be used to identify both pan-Baltic and subregional scale management priorities and to illustrate the interconnectedness between goals linked by cumulative pressures. Hence, the information provided by the BHI tool and its further development will contribute towards the fulfilment of the UN Agenda 2030 and its Sustainability Development Goals. A free Plain Language Summary can be found within the Supporting Information of this article. A free Plain Language Summary can be found within the Supporting Information of this article.
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- Hering, Bernhard J., et al.
(author)
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Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia
- 2016
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In: Diabetes Care. - : American Diabetes Association. - 0149-5992 .- 1935-5548. ; 39:7, s. 1230-1240
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Journal article (peer-reviewed)abstract
- OBJECTIVE Impaired awareness of hypoglycemia (IAH) and severe hypoglycemic events (SHEs) cause substantial morbidity and mortality in patients with type 1 diabetes (T1D). Current therapies are effective in preventing SHEs in 50-80% of patients with IAH and SHEs, leaving a substantial number of patients at risk. We evaluated the effectiveness and safety of a standardized human pancreatic islet product in subjects in whom IAH and SHEs persisted despite medical treatment. RESEARCH DESIGN AND METHODS This multicenter, single-arm, phase 3 study of the investigational product purified human pancreatic islets (PHPI) was conducted at eight centers in North America. Forty-eight adults with T1D for >5 years, absent stimulated C-peptide, and documented IAH and SHEs despite expert care were enrolled. Each received immunosuppression and one or more transplants of PHPI, manufactured on-site under good manufacturing practice conditions using a common batch record and standardized lot release criteria and test methods. The primary end point was the achievement of HbA(1c) <7.0% (53 mmol/mol) at day 365 and freedom from SHEs from day 28 to day 365 after the first transplant. RESULTS The primary end point was successfully met by 87.5% of subjects at 1 year and by 71% at 2 years. The median HbA(1c) level was 5.6% (38 mmol/mol) at both 1 and 2 years. Hypoglycemia awareness was restored, with highly significant improvements in Clarke and HYPO scores (P > 0.0001). No study-related deaths or disabilities occurred. Five of the enrollees (10.4%) experienced bleeds requiring transfusions (corresponding to 5 of 75 procedures), and two enrollees (4.1%) had infections attributed to immunosuppression. Glomerular filtration rate decreased significantly on immunosuppression, and donor-specific antibodies developed in two patients. CONCLUSIONS Transplanted PHPI provided glycemic control, restoration of hypoglycemia awareness, and protection from SHEs in subjects with intractable IAH and SHEs. Safety events occurred related to the infusion procedure and immunosuppression, including bleeding and decreased renal function. Islet transplantation should be considered for patients with T1D and IAH in whom other, less invasive current treatments have been ineffective in preventing SHEs.
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- Markmann, James F., et al.
(author)
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Executive Summary of IPITA-TTS Opinion Leaders Report on the Future of beta-Cell Replacement
- 2016
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In: Transplantation. - 0041-1337 .- 1534-6080. ; 100:7, s. E25-E31
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Research review (peer-reviewed)abstract
- The International Pancreas and Islet Transplant Association (IPITA), in conjunction with the Transplantation Society (TTS), convened a workshop to consider the future of pancreas and islet transplantation in the context of potential competing technologies that are under development, including the artificial pancreas, transplantation tolerance, xenotransplantation, encapsulation, stem cell derived beta cells, beta cell proliferation, and endogenous regeneration. Separate workgroups for each topic and then the collective group reviewed the state of the art, hurdles to application, and proposed research agenda for each therapy that would allow widespread application. Herein we present the executive summary of this workshop that focuses on obstacles to application and the research agenda to overcome them; the full length article with detailed background for each topic is published as an online supplement to Transplantation.
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- Markmann, James F., et al.
(author)
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Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes
- 2021
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In: American Journal of Transplantation. - : John Wiley & Sons. - 1600-6135 .- 1600-6143. ; 21:4, s. 1477-1492
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Journal article (peer-reviewed)abstract
- Allogeneic islet transplant offers a minimally invasive option for beta cell replacement in the treatment of type 1 diabetes (T1D). The CIT consortium trial of purified human pancreatic islets (PHPI) in patients with T1D after kidney transplant (CIT06), a National Institutes of Health-sponsored phase 3, prospective, open-label, single-arm pivotal trial of PHPI, was conducted in 24 patients with impaired awareness of hypoglycemia while receiving intensive insulin therapy. PHPI were manufactured using standardized processes. PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events and HbA(1c) <= 6.5% or reduced by >= 1 percentage point at 1 year posttransplant. Median HbA(1c)declined from 8.1% before to 6.0% at 1 year and 6.3% at 2 and 3 years following transplant (P < .001 for all vs baseline), with related improvements in hypoglycemia awareness and glucose variability. The improved metabolic control was associated with better health-related and diabetes-related quality of life. The procedure was safe and kidney allograft function remained stable after 3 years. These results add to evidence establishing allogeneic islet transplant as a safe and effective treatment for patients with T1D and unstable glucose control despite intensive insulin treatment, supporting the indication for PHPI in the post-renal transplant setting.
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