A woman with type 1 diabetes started producing her insulin less than 3 months after receiving an injection of a stem-cell-derived treatment. She remained free from insulin injections one year after treatment.
The case is the first of its kind, and two more people have been enrolled in the clinical trial in China since researchers involved in the study told Medical News Today.
Highlights
- A woman has undergone a stem-cell therapy made from her cells, to treat her type 1 diabetes.
- Researchers in China discovered the woman did not need to use insulin 75 days after the procedure, and that the stem-cell-derived islet cells she was injected with had been engrafted inside her abdomen.
- More people have been enrolled in this trial and other stem-cell therapy trials at several sites around the world.
Hongkui Deng, PhD, lead author of the new study — which appears in CellTrusted Source — and cell biologist at Peking University, Beijing, China, who has previously done groundbreaking work developing induced pluripotent stem cells told MNT that:
“The trial is ongoing and includes three patients in total. After [an] interim analysis of the [data of the] first patient and the submission of this work, the second and third patients were enrolled. Follow-up with these patients is ongoing, as they were sequentially enrolled in accordance with regulatory safety requirements. [A] long-term follow-up of at least 2 years will be conducted.”
Other stem-cell-based therapies for type 1 and type 2 diabetes are also currently in development and trials.
Stem-cell therapy reverses type 1 diabetes in case study
For this case study, researchers based in Tianjin First Central Hospital, Nankai University, Tianjin, China took fat cells from a 25-year-old woman with type 1 diabetes and chemically induced them to behave as pluripotent stem cells, a type of cell that can develop into other types of cell.
They then used these to create islet cells, which typically exist in the pancreas and create insulin, a hormone that regulates levels of glucose (sugar) in the bloodstream.
Type 1 diabetes is an autoimmune condition that results in the destruction of these islet cells by the immune system. This means that the body can not create as much insulin as needed which results in chronic, high blood glucose which can lead to complications including vascular problems that affect eyesight, can cause nerve and kidney damage.
The patient in this case study had previously had two liver transplants and a failed pancreas transplant due to complications that had arisen due to her diabetes.
The induced islet cells made from the patient’s cells were then injected between the skin and abdominal muscles. Researchers discovered that these successfully engrafted in the patient, including growing their vasculature.
Researchers found that the woman no longer needed insulin injections from around 2 and a half months after they had carried out the procedure, and at the 1-year mark she still had no need for insulin injections.
Before the procedure, she produced enough insulin to reach her target glycemic range 43.18% of the time, and 4 months later this increased to 96.2% of the time. She was also shown to have lower glycated haemoglobin, which indicated long-term systemic glucose levels at a non-diabetic level.
Are there other trials showing that stem-cell therapy can treat diabetes?
Though this is the first case study available of a person who has continued to produce insulin 1 year after receiving stem cell-based therapies, other trials are ongoing to develop a stem cell treatment for people with type 1 and 2 diabetes.
In June 2024, the pharmaceutical company Vertex announced results from its phase 1/2 clinical trial on the use of stem-cell-derived type 1 diabetes treatments at the American Diabetes Association 84th Scientific Sessions.
The trial results, based on the data of 12 people with type 1 diabetes, looked at the introduction of stem-cell-derived insulin-producing islet cells. The trial was expanded to a total of 37 people at the time the company reported the result in June.
Previously, safety data from a trial in Canada, which aimed to determine the safety of engrafting insulin-producing stem-cell-derived pancreatic endoderm cells into 17 participants, appeared in Cell Reports Medicine in 2021.
The first author of the Cell Reports Medicine study, James Shapiro, who is a professor of surgery at the University of Alberta, shared with MNT his thoughts on the latest breakthrough now reported in Cell.
He said: “I’m not at all surprised [by the results] — we have been working on this also for the past 5 years, making insulin-producing islets and reversing diabetes in mice reliably using human stem cell islets. The beauty of this approach is that they are the patient’s cells — so organ and tissue rejection is not a concern, and no or far less anti-rejection medications are needed. But I am indeed exceedingly impressed with the stunning results the Tianjin Team achieved in their first patient. This is truly incredible.”
What are the next steps in stem-cell therapy for diabetes research?
Shapiro told us he was interested in continuing to work with other teams to overcome some of the challenges that were still faced in making stem-cell treatments for people with type 1 diabetes.
“There are still lots of things to sort out,“ he pointed out. “Firstly, how can this process be expanded and accelerated to treat many more patients?“
“Secondly, can this be done without any medications for patients with autoimmune (type 1) diabetes? Third, more time and safety testing will be needed to make sure there are no unwanted — or ‘off-target’ — cells generated in the process,” noted Shapiro.
Deng concurred, telling MNT that the “challenges that need to be addressed in the field of stem cell-derived islet transplantation for diabetes therapy to extend its clinical benefits to many more patients include [the] development of appropriate immunomodulatory strategies, and the clinical manufacture of stem cell-derived islets efficiently and cost-effectively.”
