The DOI matches its Crossref record; 25 of the 27 references it cites were found in a registry or an index.
Transplantation of macroencapsulated human islets within the bioartificial pancreas βAir to patients with type 1 diabetes mellitus
Open accessAbstract
Macroencapsulation devices provide the dual possibility of immunoprotecting transplanted cells while also being retrievable, the latter bearing importance for safety in future trials with stem cell-derived cells. However, macroencapsulation entails a problem with oxygen supply to the encapsulated cells. The βAir device solves this with an incorporated refillable oxygen tank. This phase 1 study evaluated the safety and efficacy of implanting the βAir device containing allogeneic human pancreatic islets into patients with type 1 diabetes. Four patients were transplanted with 1-2 βAir devices, each containing 155 000-180 000 islet equivalents (ie, 1800-4600 islet equivalents per kg body weight), and monitored for 3-6 months, followed by the recovery of devices. Implantation of the βAir device was safe and successfully prevented immunization and rejection of the transplanted tissue. However, although beta cells survived in the device, only minute levels of circulating C-peptide were observed with no impact on metabolic control. Fibrotic tissue with immune cells was formed in capsule surroundings. Recovered devices displayed a blunted glucose-stimulated insulin response, and amyloid formation in the endocrine tissue. We conclude that the βAir device is safe and can support survival of allogeneic islets for several months, although the function of the transplanted cells was limited (Clinicaltrials.gov: NCT02064309).
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“these macroencapsulation devices can also promote fibrosis around the implant, further preventing nutrient diffusion.”
From Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes (2023) · cites this paper as [92]
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MethodPreferences of Type 1 Diabetic Patients on Devices for Islet Transplantation
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InfluentialPancreatic Islet Transplantation: A Surgical Approach to Type 1 Diabetes Treatment
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Self-citationFrom insulin replacement to bioengineered, encapsulated organoids
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“Active oxygenation can sustain human islets without immunosuppression but adds hardware and further failure modes (Ludwig et al., 2013; Carlsson et al., 2018; Krishnan et al., 2026); prevascularisation improves access to perfused tissue but recruits host vasculature to a membrane whose function…”
Engineering the Immune–Stromal Microenvironment: A Design Framework for Regenerative Biomaterials
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“…in clinical trials, predominantly for islet implantation in type 1 diabetes (PEC-Encap, NCT02239354; βAir, NCT02064309; VX-264, NCT05791201)( 10, 24 ), yet long-term therapeutic efficacy has been limited, with fibrotic reactions and inadequate mass transfer consistently identified as the…”
Microscale strategies in engineering the pancreas: Toward clinical translation
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“Among these, the b Air device, which utilizes an exogeneous oxygen supply has advanced to clinical trials but has not successfully demonstrated therapeutic glucose control or insulin independence 13,14 .”
BackgroundMethodInfluentialReversing Type 1 Diabetes: The Magnifying Potential of Stem Cell Encapsulation
Bagherian, A., Jain, A., Prathap, D., & Nguyen, V. (2022) · Berkeley Pharma Tech Journal of Medicine · doi:10.52243/bptjm.v1i2.27
Exploring Insulin Production Following Alveolar Islet Transplantation (AIT)
Lau, H., Khosrawipour, T., Li, S., Alexander, M., Frelkiewicz, P., Labbé, M. K., Stieglitz, S., Lakey, J. R. T., Kielan, W., & Khosrawipour, V. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms221910185
Insulines intelligentes et pancréas bioartificiel dans le DT1 : acteurs de demain, vraiment?
Maillard, É., Sigrist, S., Meyer, L., & Jeandidier, N. (2021) · Médecine des Maladies Métaboliques · doi:10.1016/s1957-2557(21)00180-2
Regenerative Medicine in Diabetes
Sumi, S. (2020) · Biomedicines · doi:10.3390/biomedicines8120537
“A clinical trial of the macroencapsulated human islets using the βAir device that needs daily oxygen injection has been reported [14].”
MethodJacob, A., Southard, S. M., & Rust, W. (2020) · Current Transplantation Reports · doi:10.1007/s40472-020-00281-3
Asthana, A., Muir, S. M., Chaimov, D., & Orlando, G. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-814831-0.00025-7
Challenges in the development of immunoisolation devices
Bochenek, M. A., Delcassian, D., & Anderson, D. G. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-818422-6.00023-x
Latres, E. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-814831-0.00036-1
Alginate for delivery of sensitive molecules and cells for diabetes treatment
Kumar, A., & Kumar, A. (2019) · Polysaccharide Carriers for Drug Delivery · doi:10.1016/b978-0-08-102553-6.00005-2
Metadata
- Authors
- Carlsson, P.-O., Espes, D., Sedigh, A., Rotem, A., Zimerman, B., Grinberg, H., Goldman, T., Barkai, U., Avni, Y., Westermark, G. T., Carlbom, L., Ahlström, H., Eriksson, O., Olerud, J., & Korsgren, O.
- Affiliations
- Uppsala University (SE)
- Beta-O2 Technologies (Israel) (IL)
- Corresponding author
- Carlsson, Per-Ola
- ORCID
- Venue
- American Journal of Transplantation
- Publisher
- Elsevier BV
- Published
- 2018-07
- Volume
- 18
- Issue
- 7
- Pages
- 1735-1744
- ISSN
- 1600-6135 (ISSN-L)
- PMC
- PMC6055594
- OpenAlex
- W2777721344
- Cited by
- 205
- References
- 27
- Citations by year
- 2026: 22 · 2025: 15 · 2024: 21 · 2023: 22 · 2022: 23 · 2021: 31 · 2020: 32 · 2019: 26 · 2018: 12
- FWCI
- 19.90
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- American Journal of Transplantation (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- KTH Publication Database DiVA (KTH Royal Institute of Technology) (submittedVersion, other-oa)
- Funders
- Juvenile Diabetes Research Foundation International
- Diabetes Research & Wellness Foundation
- Stiftelsen Familjen Ernfors Fond
- Diabetesfonden
- Vetenskapsrådet (921-2014-7054, K2013-55X-15043, K2015-54X-12219-19-4, K2016-01040, K2016-GTW)
- Novo Nordisk
- European Research Council (F4-2013-602889, 646075-ELASTISLET)
- Leona M. and Harry B. Helmsley Charitable Trust
- Barndiabetesfonden
- EXODIAB
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pancreatic function and diabetes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- macroencapsulation, bioartificial pancreas, type 1 diabetes, islet transplantation, oxygen supply, immunoprotection, islet survival, C-peptide, amyloid fibril formation, capsule fibrosis, device retrieval, treatment efficacy and safety
- MeSH terms
- Adolescent, Blood Glucose, Capsules, Child, Child, Preschool, Diabetes Mellitus, Type 1, Female, Follow-Up Studies, Humans, Islets of Langerhans, Male, Monitoring, Physiologic, Prognosis, Islets of Langerhans Transplantation, Pancreas, Artificial, Bioartificial Organs
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