Methods for monitoring physiological status of a body organ

Inventors

Berggren, Per-Olof

Assignees

Biocrine AB

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Publication Number

US-9462973-B2

Patent

Publication Date

2016-10-11

Expiration Date


Abstract

The present invention provides method for monitoring physiological status of an organ in a subject by monitoring morphological changes over time in transplanted tissue on an eye of the subject.

Core Innovation

The invention provides a method for monitoring a physiological status of an in situ pancreas in a human subject during a course of treatment. The method comprises monitoring morphological changes over time in transplanted pancreatic islets of Langerhans transplanted on an eye of the human subject.

The morphological changes over time in the transplanted pancreatic islets tissue on the eye of the subject are used to indicate a physiological status of the in situ pancreas in the human subject during a course of treatment. In representative embodiments, the monitoring includes longitudinal in vivo imaging of islet morphological parameters including cellular and functional measures that reflect the condition of the pancreas.

The disclosure further characterizes how the approach is used to monitor treatment efficacy, where morphological changes over time indicate an effect of a therapeutic, test compound, or diet and/or exercise regimen. The document also describes monitoring across time for changes associated with islet growth, vascularization, beta-cell proliferation, and regranulation in transplanted pancreatic islets.

Claims Coverage

The independent claim covers a longitudinal monitoring method linking morphological changes in transplanted pancreatic islets on an eye to the physiological status of an in situ pancreas during treatment. Across dependent claims, the inventive subject matter is narrowed by specifying microscopy-based monitoring, a selected enumerated group of islet morphological parameters, eye location for islet transplantation, and timing with two or more time points after administering treatment.

Longitudinal monitoring of physiological status via islet morphological changes on an eye

Monitoring morphological changes over time in transplanted pancreatic islets of Langerhans transplanted on an eye, wherein the morphological changes indicate a physiological status of the in situ pancreas in the human subject during a course of treatment.

Microscopy-based determination of morphological changes

Monitoring morphological changes using microscopy.

Selection of monitored morphological changes from an enumerated set

Choosing the morphological changes from a listed set of pancreatic-islet cellular and functional parameters.

Transplantation into the anterior chamber of the eye

Transplanting pancreatic islets into an anterior chamber of the subject’s eye.

Assessment at two or more time points after administering

Determining morphological changes in the transplanted pancreatic islets at two or more time points after administering.

Treatment efficacy monitoring for diabetes

Applying the method to a course of treatment for a disorder that is diabetes.

Overall, the claim set ties physiological status of an in situ pancreas to longitudinal morphological changes observed in transplanted pancreatic islets on an eye, with claim refinements covering microscopy, selected parameter sets, anterior chamber placement, assessment timing, and a diabetes treatment-efficacy context.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Monitoring physiological status of an in situ pancreas in a human subject during a course of treatment, using longitudinal imaging of transplanted pancreatic islets of Langerhans on an eye.

Monitoring treatment efficacy for pancreatic disorders, including diabetes, using morphological changes over time in transplanted pancreatic islets.

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