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A Possible Solution

There is hope! There is currently an experimental procedure being  handled by the National

Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that is researching ways to transplant a deceased organ donor's Islet of Langerhans cells into a Type I diabetic candidate. From reading the studies and reports of the experimental procedure, I've observed that although this does not provide guaranteed treatment for all, it gives hope for those who have been suffering the longest. 

The procedure has been known as Pancreatic Islet Transplantation and what happens is

that doctors take pancreatic islets from a deceased donor and deliver them to the recipient patient via catheter into the hepatic portal vein. At this point, the islet cells will implant in the liver and begin creating insulin. It is critical that once the cells are harvested from the donor, they are to be transplanted into the recipient immediately. Of course a protocol must be followed, but there is not time for delay. Once the doctors have harvested the cells, they are taken to the lab where they are purified and counted. How many cells do the doctors know to harvest? Each candidate differs in size and weight therefore they are to be given at least 10,000 islet cells per kilogram of body weight.

While this sounds like a big advancement in modern medicine, there are still some

drawbacks. This procedure may not be a solution for all Type I diabetic individuals as there is criteria that each candidate must meet. Based off of criteria standards, doctors must decide whether or not the transplant's benefits will outweigh the possible dangers in each individual. Since the beginning of Phase three of the trial, the National Institutes of Health has found that between the years 1999 and 2015, 1,086 people have received a pancreatic islet transplant. Within the study, the NIH has found that one year after transplantation, 9 out of 10 recipients had an A1C level below 7% and did not experience hypoglycemic episodes with about half of them needed insulin. Following two years after transplantation, 7 out of 10 recipients had an A1C level below 7% with none of them experiencing a hypoglycemic episode and only 4 out 10 of them needed insulin. There is also a worldwide shortage of pancreatic donors therefore the resources are scarce and may not be able to treat every Type I diabetic.

Ongoing research proves success and improved quality of life despite some individuals still

in need of insulin. Further research is still needed to be done before this is able to mass treat people on a larger scale.

Candidate Criteria

Unfortunately this procedure is not

for everyone. In some individuals, the risk of rejection outweigh all the benefits of proceeding with the transplant. The extensive and completed list of qualifying and exclusion criteria is can be found on the NIH website, but here is a summarized list.

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Inclusion Criteria:

  • Candidates must be of sound mind and compliant with the study's procedures.

  • At least one documented episode of severe hypoglycemia with memory loss, confusion, uncontrollable behavior, seizure, vision loss, and/or loss of consciousness within the past twelve months prior to study enrollment.

  • Absent stimulated C-peptide 60-90 minutes post-mixed-meal tolerance test.

  • Dependent on insulin for at least five years upon study entry

  • Between the ages of 28-40

  • At least three evaluations from an Endocrinologist, Diabetologist, or other diabetes specialist.

  • Monitored blood glucose levels no less than three times a day.

  • Administered insulin more than three times a day or insulin pump therapy.

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Exclusion Criteria:

  • Blood pressure higher than 160/100 mmHg.

  • BMI greater than 30kg/m^2 or weight less than or equal to 50kg.

  • Known alcohol or substance abuse

  • Heart attack six months prior to entry study

  • Symptomatic cholecystolithiasis (gallstones)

  • Acute or chronic pancreatitis 

  • Previous islet transplant

  • Symptomatic peptic ulcer disease

  • Evidence of ischemia on functional heart exam within the year prior to study entry

Risks

With any transplant, there is

always the possibility of risky complications. Candidates who undergo this transplant will be risking bleeding, blood clots, and pain after the procedure. In Type I diabetics, because the body already recognizes its own cells as foreign, there is a chance it will also recognize the transplanted cells as foreign and begin rejecting them. Anti-rejection medication is typically given to the patient long term in order to prevent a failed transplant however that comes with it's own complications. The body may also create antibodies against the donor cells therefore making it difficult for the body to accept the donation. 

Anti-rejection meds, also known as

immunosuppressants are given however these increase the risk of other diseases and possibly cancer to develop within the person. Immunosuppressant meds may also cause:​

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A new immunosuppressant

protocol is being reviewed right now and it suggests that as soon as the procedure is over, a combination of anti-rejection meds called daclizumab, sirolimus, and tacrolimus are to be given. Daclisumab is to be given via IV and discontinued while sirolimus and tacrolimus are to be prescribed long-term.

At the moment, researchers are

looking for ways that islet cell recipients can live without long-term immunosuppressant use. A method called "encapsulation" is being discussed and through this, the cells will be coated in a material that will prevent the body from attacking the cells.

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