Protecting the Insulin the Body Can Still Make
Type 1 diabetes develops when the immune system attacks the pancreatic beta cells responsible for producing insulin.
By the time someone is diagnosed, many of these cells have already been lost, but some insulin-producing ability may still remain. Protecting that remaining function could potentially help slow the progression of the disease.
A Phase I/II clinical trial in Sweden explored whether mesenchymal stromal cells derived from Wharton’s Jelly in the umbilical cord could help preserve the body’s natural insulin production in adults recently diagnosed with type 1 diabetes.
How the Study Worked
The trial included 24 adults between 18 and 40 years old who had been diagnosed with type 1 diabetes less than two years earlier.
The study took place in two stages. First, nine participants received different doses of a Wharton’s Jelly MSC product called ProTrans to evaluate safety and help determine the most appropriate dose.
Researchers then conducted a randomized, double-blind, placebo-controlled portion involving 15 participants. Ten received 200 million MSCs through a single IV infusion, while five received a placebo. Neither the participants nor the study staff knew which treatment each person received during the trial. Researchers followed them for one year.
A Noticeable Difference in Natural Insulin Production
One of the most important measurements was C-peptide.
C-peptide is released when the pancreas makes insulin, so measuring it gives researchers a useful way to estimate how much insulin the body is still producing on its own.
After 12 months, C-peptide levels in the placebo group had fallen by 47%. In comparison, participants who received ProTrans experienced only a 10% decline.
That difference was statistically significant, suggesting the UC-MSC treatment helped preserve more of the participants’ remaining beta-cell function during the first year.
Insulin Needs Stayed Stable
Researchers also looked at how much injected insulin participants needed. Over the year, people in the placebo group increased their insulin use by a median of 10 units per day. Meanwhile, insulin requirements in the ProTrans group did not increase overall.
This doesn’t mean the treatment eliminated the need for insulin. Every participant continued using insulin, and no one became insulin-independent during the study. Instead, the interesting finding was that the UC-MSC group appeared to maintain more of their existing insulin-producing ability while their insulin needs remained relatively stable.
How Did the Treatment Perform for Safety?
Safety was another major focus of this early-stage trial. All participants receiving ProTrans tolerated the infusion, and researchers reported no serious adverse events related to the treatment.
Most side effects were mild and temporary. Two participants experienced reactions linked to the infusion itself; one reported a temporary unusual smell sensation, while another developed a short-lived headache. Researchers also found no evidence that the donor-derived cells triggered the type of immune response they were specifically monitoring for.
Why Wharton’s Jelly MSCs?
The MSCs used in this study came from Wharton’s Jelly, the supportive tissue found inside the umbilical cord. Rather than replacing beta cells directly, researchers are interested in these cells partly because of their ability to interact with and influence the immune system.
That could be especially relevant in type 1 diabetes, where an abnormal immune response is responsible for damaging insulin-producing cells in the first place.
The ProTrans product was also created by pooling MSCs from five umbilical cord donors, with the goal of producing a more consistent, ready-to-use cell therapy.
An Encouraging Early Step
This was a small clinical trial, and there are important limitations. Only 15 participants were included in the randomized portion, the groups had some differences in C-peptide levels before treatment, and follow-up lasted one year. The treatment also did not make participants insulin-independent or produce a significant difference in HbA1c levels.
Still, the main finding was encouraging: a single infusion of Wharton’s Jelly-derived MSCs was associated with significantly better preservation of the body’s own insulin production compared with placebo.
Researchers are continuing longer-term follow-up to learn whether that benefit lasts and whether treatment could ultimately help slow the progression of type 1 diabetes.
For regenerative medicine, the study highlights an interesting possibility; not necessarily replacing what the body has lost, but helping protect the function it still has.
Source
Carlsson PO, Espes D, Sisay S, et al. Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial. Diabetologia. 2023;66:1431–1441. doi: 10.1007/s00125-023-05934-3. Available from: https://link.springer.com/article/10.1007/s00125-023-05934-3
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