Stem Cell Research: Diabetes

Research into Stem Cells for Diabetes has been a big focus for a few biotech companies. 

We’ve broken down each study for both Type 1 & Type 2 diabetes in detail, but we know it’s a lot to digest. 

At the start of the article, we’ve provided an initial summary of what all the research is telling us & a conclusion at the end.

If you want to look at any study in particular, use the Content Table on the left to go to a particular study.

We hope this is helpful!

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Stem Cell Research for Type 1 Diabetes

Phase III Vertex Stem Cell Trial for Diabetes: VX-880 Zimislecel: USA: Ongoing

You can read the results of their Phase I/II Results on their press release in 2025.

This is an ongoing clinical trial sponsored by Vertex Pharmaceuticals Incorporated to evaluate the safety, tolerability, and effectiveness of an investigational stem cell therapy called VX-880. The therapy is designed to treat Type 1 Diabetes in patients who have a history of severe hypoglycemia (dangerously low blood sugar) 

Participants:

• The trial is currently recruiting and aims to enroll an estimated 52 participants.
• To be eligible, patients must have had Type 1 Diabetes for at least five years and have experienced at least two episodes of severe hypoglycemia in the past 12 months.
• To prevent the patient’s immune system from attacking and rejecting the new cells, they are given a regimen of immunosuppressant drugs

Procedure:

• Cell Type & Source:
  • The cells are derived from embryonic stem cells
  • Vertex have a proprietary technology which allows them to grow the cells and differentiate them into Islet Cells
• Delivery Method:
  • The cells are injected directly into the hepatic portal vein, which is a blood vessel leading to the liver.

Key Results: The results below are from the Phase 1/2 portion of the trial, which led to its expansion to Phase 3.

• Insulin Independence:
  • Ten of the 12 patients (83%) were insulin-free at the one-year mark.
  • Overall, the group showed an average reduction in their daily insulin dose of 92%.
• Blood Sugar Control
  •  All 12 participants achieved the ADA’s recommended blood sugar targets.
  • They all had an HbA1c (a measure of long-term blood sugar control) of less than 7% and maintained their blood sugar levels within a healthy range (>70% time-in-range).
• Safety:
  • The therapy was generally well-tolerated, with most side effects being mild or moderate.
  • There were no serious adverse events related to the treatment. Importantly.
  • All participants were free of severe hypoglycemic events from day 90 onward, achieving the primary endpoint for this phase of the study.
• Engraftment:
  • All 12 patients demonstrated successful engraftment of the cells, evidenced by their body’s ability to produce its own insulin (glucose-responsive C-peptide production)

How the Cells Worked

• The researchers believe Zimislecel works as a direct cell replacement to restore the body’s ability to regulate glucose. 
• The transplanted cells are “fully differentiated” and intended to function just like a healthy person’s own islet cells, producing insulin in response to blood sugar levels. 
• The goal is to restore pancreatic islet cell function and glucose-responsive insulin production.

Next Steps

• The positive and consistent results from the Phase 1/2 portion of the trial have allowed it to progress to Phase 3. 
• Vertex has now completed enrollment and dosing in the expanded program and anticipates making regulatory submissions as early as next year.

Phase I/II Perinatal Stem Cell Study for Type 1 Diabetes: Creative Medical Technology  CELZ-201: USA: Ongoing

You can read more on the protocols of this study on their clinical trials page.

This study is a Phase I/IIa clinical trial to evaluate a therapy called CELZ-201 as a treatment for newly diagnosed Type 1 diabetes (T1D).

The trial is being conducted at the Diabetes Research Institute at the University of Miami Miller School of Medicine, and the objective is to determine the safety and effectiveness of the therapy.

Methodology

• Participants: The study plans to enroll 18 adults between the ages of 18 and 35. All participants must have been diagnosed with Type 1 diabetes within the last 180 days and still have some of their own insulin production.
• Procedure: Participants are split into two groups. The treatment group (12 patients) receives a single dose of CELZ-201, along with standard diabetes care.
  The control group (6 patients) receives only standard care.
  The dose is delivered through an intra-arterial infusion, meaning it’s injected directly into an artery near the pancreas.
  The study is open-label, so everyone knows who is receiving the treatment.
• Cells Used: The therapy uses a type of cell called CELZ-201, which is a perinatal tissue-derived cell (PRDC).
  This means the cells are sourced from tissues that are normally discarded after birth, like the umbilical cord and placenta.
  The cells are allogeneic and are a type of “off-the-shelf” product.

How researchers think cells will work

• The researchers hypothesize that the cells work by protecting and preserving the remaining insulin-producing cells in the pancreas.
• The therapy is designed to have properties that allow it to be safely used in a patient without being rejected by their immune system.
• By targeting patients early in their diagnosis, the goal is to use the cells to stop the immune system from destroying the remaining insulin-producing cells.
• And to potentially help them function better, which could reduce the patient’s dependence on daily insulin injections.

Chemically Reprogrammed iPSC Stem Cell Study on Single Patient: China: Ongoing

You can read more about this study in the journal Cell.

This study is a first-in-human trial that assessed the safety and effectiveness of chemically reprogrammed iPSC Stem Cells for a single patient with severe Type 1 Diabetes. It’s the first time this specific type of therapy was used in a clinical setting.

The main goal was to assess if the treatment was safe and if it could restore insulin independence and blood sugar control for a patient who had a difficult medical history. They were also unable to manage her diabetes with conventional treatments.

The research was conducted by scientists and doctors in China.

Participant

• A single 25-year-old female patient with an 11-year history of Type 1 Diabetes. 
• Her diabetes was difficult to control and she had a history of complications, including two prior liver transplants and a failed pancreas transplant.

Procedure

• Delivery Method: The patient’s new insulin-producing cells were injected into a new location: a specialized space under her abdominal muscles, known as the anterior rectus sheath.
  This site was chosen because it’s easily accessible for monitoring and provides a good environment for the cells to survive.
• Cell Type & Source: The study used the patient’s own stem cells that were derived from her fat tissue
  • Reprogramming: Researchers used a unique method called chemical reprogramming to turn the patient’s fat-derived cells into a type of master cell called chemically induced pluripotent stem cells (CiPSCs).
  • Differentiation: These CiPSCs were then “trained” through a step-by-step process in the lab to mature into insulin-producing cells, which the researchers call CiPSC-islets.
    Dosage: The patient received a total dose of 1,488,283 insulin-producing islet cells.
• Cell Quality: Before use, the cells underwent extensive testing to confirm their identity, safety, and ability to produce insulin

Key Results

The treatment successfully restored the patient’s natural insulin production and blood sugar control, allowing her to stop using insulin injections completely for a full year. 

• Insulin Independence:
  • The patient’s daily insulin dose dropped from a high of 54 units per day before the transplant and reached zero on day 75.
  • This independence was maintained for the rest of the year.
• Blood Sugar Control:
  • Time in Range (TIR):
    • This measures how long a person’s blood sugar stays within a healthy target range. 
    • The patient’s TIR dramatically improved from 43.18% before the transplant to over 98% for eight months of the follow-up year, which is significantly better than the standard goal of 70%.
  • HbA1c:
    • This test provides a picture of a person’s average blood sugar over three months. 
    • The patient’s level dropped from a high of 7.57% at the start to a non-diabetic level of 5.37% by day 120 and remained there.
  • Graft Function & Safety
    • Insulin Production:
      • Before the transplant, the patient had no detectable C-peptide, which confirms her body wasn’t making its own insulin.
      • After the transplant, her C-peptide levels rose and stabilized, showing that the new cells were successfully producing insulin.
    • No Tumors:
      • A major safety concern for this type of therapy is the risk of tumors.
        The researchers continuously monitored the transplanted cells using MRI scans and blood tests for tumor markers.
      • The results showed no evidence of any abnormal growth or tumors after one year.
    • Adverse Events:
      • The treatment was considered safe, with no severe adverse events related to the procedure.
      • Minor events, like pain at the injection site, were resolved quickly.

How the Cells Worked

• The study suggests that the transplanted cells, by acting as a new source of insulin, were able to directly take over the function of the patient’s destroyed pancreatic cells.
• This restored her body’s ability to produce insulin in response to blood sugar levels.
• This is a case of direct cell replacement therapy, where the new cells are providing a missing function, rather than simply sending out “healing signals” to other cells.

What We Don’t Know (Limitations)

• Single Patient: Since this study only involved one patient, the results cannot be generalized to a larger population. More patients need to be studied to confirm these findings.
• Immunosuppression: The patient was already on immunosuppressant medication due to her prior liver transplants. While this allowed the researchers to test the new cells without adding to her medication burden, it means we don’t know how the therapy would work in a patient who isn’t already taking these drugs. Since Type 1 Diabetes is an autoimmune disease, it’s highly likely that immunosuppression would still be needed to prevent the body from attacking the new cells.
• Long-Term Effects: The follow-up period was only one year, so the long-term effectiveness and safety of the treatment are still unknown.

Next Steps

This was an exploratory Phase I clinical trial and the results from this patient were encouraging enough to warrant further investigation. The trial is ongoing and has since enrolled two more patients. The researchers believe these findings mark a significant step forward in developing personalized medicine using stem cells to treat Type 1 Diabetes.

2024 Stem Cell Educator Therapy in Type 1 Diabetes: A Pilot Study: USA

You can read more about the study on their Clinical Trials Page.

This is a pilot clinical study to assess the safety, feasibility, and efficacy of Stem Cell Educator Therapy for the treatment of patients with Type 1 diabetes. The study was led by researchers at Hackensack Meridian Health in New Jersey.

Participants:

• The study enrolled 13 adult patients with Type 1 diabetes.
• All participants had to have a blood test confirming the presence of autoantibodies (a key marker of the disease) and still have some level of insulin production.

Procedure:

• Patients received Stem Cell Educator Therapy in an open-label, single-group design.
• Meaning all patients received the treatment and there was no placebo group.

The “Education” Process:

• This therapy is unique because the stem cells are not injected into the patient’s body.
• Instead, the patient’s blood is circulated through a machine that separates their immune cells, called lymphocytes.
• These lymphocytes are then briefly “co-cultured,” or grown together with, human cord blood-derived multipotent stem cells (CB-SCs).
• This interaction “educates” the lymphocytes & the “educated” cells are then returned to the patient.
• The goal is for the educated immune cells to create “immune balance” and stop attacking the pancreas.

Researchers’ Conclusions

This pilot study successfully demonstrated that the Stem Cell Educator Therapy can be a safe approach for treating Type 1 diabetes. The therapy has the potential to treat the underlying cause of immune-related diseases by restoring immune balance.

2024 VC-02 Stem Cell Study for Type 1 Diabetes: ViaCyte: USA

You can read more on this trial on Viacyte’s Clinical Trials Page. 

This is a Phase 1/2 clinical trial of a new cell replacement therapy for people with Type 1 diabetes and hypoglycemia unawareness. 

The study was sponsored by ViaCyte and collaborated with Vertex Pharmaceuticals. Its goal was to test if a new product called VC-02 could be safely implanted and effectively improve blood sugar control.

Participants:

• The study enrolled 49 adult patients with Type 1 diabetes.
• All participants had long-standing diabetes and a condition called hypoglycemia unawareness, meaning they couldn’t feel when their blood sugar dropped dangerously low.
• They also had no detectable insulin production of their own.

Delivery Method:

• The cells were delivered inside a device called VC-02 that was surgically implanted subcutaneously i.e just under the patient’s skin.
• The device was also designed to be “retrievable”
• Immunosuppressants: Because the implanted cells are from a donor, patients were required to take immunosuppressive medications to prevent their bodies from rejecting the cells.

How the Cells were Made:

1. The Starting Cells: Researchers used cells from a human embryonic stem cell line.
2. Making the Right Cells: These embryonic stem cells were then carefully guided in a lab to differentiate (or turn into) a specific type of cell called pancreatic endoderm cells (PEC-01).
3. Loading the Device: These PEC-01 cells were then loaded into a delivery device that had perforated membranes. The perforations allowed blood vessels to grow in and feed the cells, but did not protect the cells from the immune system.

Dosage:

• The implanted cell dose was, on average, 14 million cells per kilogram of body weight.
  

Results

• Follow-up duration: The primary results for safety were tracked for up to 4 months in Cohort 1, while the efficacy was measured at 26 weeks for Cohort 2.
• Primary Outcome: The main goals were to assess the safety of the product and measure the change in C-peptide levels (a sign of insulin production) after a meal.
• Key Findings:
  • C-peptide Levels: In the larger group (Cohort 2), the average change in C-peptide levels was 0.1292 ng*hour/mL at 26 weeks, showing a small but positive increase in insulin production.
  • Adverse Events: In Cohort 2, 40% of patients experienced a serious adverse event, with many of these related to the surgery or the side effects of immunosuppressive drugs.

How the Cells Worked

• The cells worked by differentiating into a new, functional β cell mass that was able to produce insulin in response to blood sugar levels.
• The implant served as a way to deliver these cells and allow them to mature inside the body.
  

Researchers’ Conclusions

The researchers concluded that the study successfully showed the feasibility of achieving a functional β cell mass from stem cells that could produce insulin in patients with Type 1 diabetes.

They noted that this approach supports the continued development of this therapy, but that further optimization is needed to improve the efficacy & address the significant safety issues associated with the surgery and immunosuppression.

2021 Placenta Derived Mesenchymal Stem Cell Phase I trial for Type 1 Diabetes: Iran

You can read more about this study which was published in the Journal of Diabetes & Metabolic Disorders in 2021.

Participants:

• The study enrolled the first four patients, who were all juveniles (ages 12-18) with newly diagnosed Type 1 diabetes.
• The study’s full design included 10 patients.

Procedure:

• Patients received a single intravenous infusion (IV) of the cells.
• The study was open-label and non-randomized, meaning there was no placebo group.

Cells Used:

• The study used Placenta-derived Mesenchymal Stem Cells (PLMSCs).
• These cells are a type of mesenchymal stem cell sourced from donated placentas

Dosage:

• The dosage was a single dose of 1 million PLMSCs per kilogram of body weight.

Cell Preparation:

• The cells were manufactured in a clean room facility using a protocol that met “Good Manufacturing Practice” (GMP) guidelines.
• The final product was checked for viability and tested to confirm that it was free from contamination.

Results

• Follow-up duration: The preliminary report covers a one-year follow-up period.
• Primary Outcome: The main goal of this Phase 1 trial was to assess the safety of the cell transplantation.
• Key Findings:
  • Safety: No serious adverse events were seen during the one-year follow-up period.
  • Efficacy: Partial Remission: Two patients experienced a partial remission.
  • Insulin Production: This remission was characterized by a temporary increase in their own insulin production, as measured by C-peptide levels.
  • Autoantibodies: There was also a temporary decrease in the autoantibodies that attack the pancreas.
• Safety:
  • One patient had a mild headache, which was successfully treated.
  • The researchers did not observe any significant changes in liver or kidney function.

How the Cells Worked

• The researchers believe the cells worked by immune modulation, which is believed to be the main mechanism for mesenchymal stem cells in Type 1 diabetes.
• Instead of replacing the damaged cells, the PLMSCs helped to calm the autoimmune reaction by down-regulating inflammation & suppressing the immune cells that attack the pancreas.
• They believe this temporary effect on the immune system may have allowed the remaining insulin-producing cells to regenerate.
  

Researchers’ Conclusions

The researchers concluded that this preliminary report demonstrated the short-term safety of PLMSC transplantation in juvenile Type 1 diabetes patients. They state that more investigation is needed to prove the long-term safety and potential effectiveness of this treatment.

Stem Cell Research for Type 2 Diabetes

2022 Phase II Clinical Trial: Umbilical Cord Derived MSC Stem Cells for Type 2 Diabetes: China

You can read more about the study which was published on BioMed Central.

This study was led by researchers from the Chinese PLA General Hospital in Beijing, China. The team ran a clinical trial to compare the effectiveness and safety of umbilical cord stem cells (UC-MSCs) against a placebo treatment for Chinese adults with type 2 diabetes. Their goal was to see if the stem cells could improve key health markers like blood sugar levels and insulin use.

Participants:

• 91 patients were enrolled in the study and were split into two groups.
• One group received the stem cell treatment (45 patients), and the other received a placebo (46 patients).

Procedure:

• Patients received three intravenous infusions (IV) of either UC-MSCs or a placebo solution, with a 4-week break between each infusion.
• The study was “double-blinded,” which means neither the patients nor the doctors knew who was getting the stem cells and who was getting the placebo.

Cells Used:

• The study used umbilical cord-derived mesenchymal stem cells. These cells came from the umbilical cords of healthy women who gave birth at the same hospital where the study was conducted.
• The researchers confirmed that these were indeed UC-MSCs by checking for specific markers on the cells’ surface.

Dosage:

• For each infusion, patients received a dose of 1 million cells per kilogram of their body weight

Culture Method:

• The UC-MSCs were isolated from the umbilical cords and then grown in a laboratory to increase their numbers for the treatments.
• Cells at “passage four” were used, meaning they had been grown and multiplied four times in the lab before being used in the study

Results

Follow-up duration: 48 weeks.

Primary Outcome:

• The main goal was to see what percentage of patients achieved an HbA1c level below 7.0% and a daily insulin reduction of 50% or more.
• After 48 weeks, 20% of the patients in the stem cell group reached this goal, compared to only 4.55% in the placebo group. This difference was considered statistically significant.

Key Findings:

• Insulin Requirement: The stem cell group showed a significantly higher percentage of insulin reduction (27.78%) compared to the placebo group (15.62%) after 48 weeks.
• HbA1c Levels: HbA1c levels decreased by 1.31% in the stem cell group versus only 0.63% in the placebo group at 48 weeks.
• Insulin Resistance: The stem cell group showed a significant improvement in insulin resistance, while the placebo group showed no significant change.
• Islet β-Cell Function: The study found no significant improvement in the function of the pancreatic islet β-cells (the cells that produce insulin) in either group.

Safety:

• No major side effects related to the stem cell treatment were reported.

How the Cells Worked

• The researchers suggest that the stem cells worked by reducing insulin resistance, which is the body’s decreased response to insulin. 
• The study found that the stem cells did not significantly improve the function of the insulin-producing cells in the pancreas.
• This suggests that the cells were not repairing the pancreas directly by turning into new cells. Instead, they likely worked through paracrine effects, meaning they sent out helpful signals to improve the environment and the way the body’s existing cells respond to insulin

Researchers’ Conclusions:

The study suggests that umbilical cord-derived stem cell therapy is a safe and effective approach for Chinese adults with type 2 diabetes. The treatment was able to reduce the amount of insulin needed and improve the body’s sensitivity to insulin. The authors conclude that this type of stem cell treatment could be a potential therapeutic option for type 2 diabetes

2024 Real World Case Study on iPSC Stem Cells Treating Type 2 Diabetes: China

You can read more on this real world study on Nature.

This is a real-world case study that reports on a single patient who received a new type of personalized stem cell-derived therapy for Type 2 diabetes. The study was led by researchers from the Shanghai Changzheng Hospital and the Shanghai Institute of Biochemistry and Cell Biology. Their goal was to investigate the safety and effectiveness of this new treatment in a patient with a long history of insulin-dependent diabetes.

Participants:

• The study involved a single patient: a 59-year-old man with a 25-year history of Type 2 diabetes.

Procedure:

• The patient received a single transplant of the new cell-based therapy.
• The cells, organized into islet tissue, were delivered to his liver through a minimally invasive procedure.

Cells Used:

• The cells were a personalized therapy created from the patient’s own body.
• Researchers took the patient’s blood cells and reprogrammed them in a lab to create induced pluripotent stem cells (iPSCs).
• These iPSCs were then guided to become specialized endoderm stem cells (EnSCs), which were finally used to create the transplanted islet tissue, called E-islets.

Dosage:

• The patient received a dose of 1.2 million E-islets.

Results

• Follow-up duration: The patient was followed for 116 weeks, which is over two years.
• Primary Outcome: The main goals were to assess the patient’s blood sugar control, the reduction in his insulin use, and the levels of C-peptide and insulin his body was producing.
• Key Findings:
  • HbA1c Levels: Dropped from 6.6% to 4.6%.
  • Insulin Production: Fasting C-peptide levels increased by 3-fold.
  • Insulin Requirement: The patient was able to completely stop his insulin injections by week 11.
  • Blood Sugar Fluctuation: The time his blood sugar was in a safe range (between 3.9 and 7.8 mmol/L) increased from 56.7% to 99%. There were no episodes of severe high or low blood sugar during the entire follow-up.
• Safety:
  • No tumor formation was detected.
  • No severe adverse events related to the transplant were reported.
  • Minor, temporary side effects included abdominal distension, loss of appetite, and minor weight loss.

How the Cells Worked

• Unlike some other stem cell therapies that rely on sending out healing signals, the researchers found that these cells worked by turning into, the new insulin-producing tissue. 
• The transplanted E-islets were able to produce insulin in response to glucose, effectively taking over the function of the patient’s own failing pancreas cells.

Researchers’ Conclusions 

The researchers concluded that this case study provides the first evidence that personalized stem cell-derived islet tissue can successfully restore the function of insulin-producing cells in a patient with late-stage Type 2 diabetes.

They believe this approach could be an effective cure for diabetes, but they noted that more studies with a larger number of patients are needed to draw definitive conclusions.

2023 Phase II Clinical Trial: Umbilical Cord Derived MSC Stem Cells for Type 2 Diabetes: China

You can read more about the study which was published in the World Journal of Clinical Cases.

This study was led by researchers from Peking University Shenzhen Hospital in Shenzhen, China. The team ran a clinical trial to evaluate the safety and tolerance of umbilical cord-mesenchymal stem cells (hUC-MSCs) against a placebo for adults with type 2 diabetes. Their main goal was to see if the treatment was safe and if it caused any side effects

Participants:

• A total of 34 patients were enrolled in the study and were split into two groups.
  • One group received the stem cell treatment (24 patients).
  • The other group received a placebo (10 patients).

Procedure:

• Patients received three intravenous (IV) infusions of either hUC-MSCs or a placebo solution, with one infusion given per week for three consecutive weeks.
• The study was “open-label and randomized”. This means that while patients were randomly assigned to a group, both patients and researchers were aware of which treatment was being administered.

Cells Used:

• The study used human umbilical cord-derived mesenchymal stem cells, which were provided by a biotech company in Shenzhen, China.
• These cells were sourced from the gelatinous tissue (Wharton’s jelly) found around umbilical vessels from donated umbilical cords.
• The researchers confirmed that these cells had a strong ability to multiply and a low risk of causing an immune reaction

Dosage:

• For each infusion, patients in the stem cell group received a dose of 1 million cells for every kilogram of their body weight
  

Culture Method:

• The hUC-MSCs were isolated and grown in a laboratory.
• The cells used in the treatment were from the “fourth passage”, meaning they had been grown and multiplied four times in the lab before being prepared for the study
  

Results

• Follow-up duration: The patients were followed for 24 weeks.
• Primary Outcome: The primary goal was to evaluate the safety of the hUC-MSC treatment

• Key Findings:
  • Safety: The study found no serious adverse events, and the treatment was well-tolerated.
  • Fever: Four patients (16.7%) in the stem cell group experienced a temporary fever, typically after the second or third infusion. No patients in the placebo group experienced this.
  • Hypoglycemia: One patient from the stem cell group had a low blood sugar attack within one month of the treatment, but the patient’s glucose level returned to normal without intervention.
  • Fatigue: Four patients in the stem cell group reported feeling tired within three days after the first infusion. This fatigue did not affect their daily life and went away on its own.
  • Immune System Markers: The study observed a temporary decrease in lymphocyte levels and an increase in immunoglobulin levels (antibodies) in the stem cell group.
  • Coagulation Markers: The stem cell treatment affected blood clotting indicators. Patients had significantly higher levels of D-dimer and fibrinogen and a lower thrombin coagulation time. The researchers recommend that coagulation function should be carefully monitored.
  • Tumor Risk: There were no signs of tumor markers or the formation of tumors or nodules in any patient during the follow-up period.

Researchers’ Conclusions

The study concluded that hUC-MSC infusions are safe and well-tolerated for the treatment of Type 2 diabetes.

The authors noted that the treatment may cause mild, short-term side effects like fever and fatigue but did not lead to any serious long-term issues.

The findings are expected to provide a strong foundation for further clinical studies on stem cell therapy for Type 2 diabetes.

The researchers also recommended that future studies should pay close attention to the effects of the treatment on blood clotting and the immune system

Reviews looking at Stem Cells Treating Diabetes

In science, a review isn’t a single experiment,it’s more like a big-picture summary. Instead of testing one small idea, reviews look at lots of different studies on the same topic, gather their results, and explain what the overall evidence shows.

Think of it as reading dozens of studies then pulling out the key takeaways. What’s promising, what’s unclear and where more research is needed

2025 Review on Stem Cell Treating Diabetes: Nigeria

You can read more about this review which was published in BMC Endocrine Disorders in 2025.

A team of scientists from various institutions, including Siberian State Medical University in Russia and the University of Nigeria, came together to review the latest research on stem cell therapies for diabetes. Their goal was to summarize the current progress and remaining challenges in this field.

What they looked at

• The researchers conducted a literature search of studies published between 2018 and 2025.

• They reviewed 13 human clinical trials that used various stem cell types to treat adults and adolescents with Type 1 or Type 2 Diabetes.

• Types of Stem Cells Reviewed:
  1. Pluripotent Stem Cells (PSCs), which include embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).
  2. Mesenchymal Stem Cells (MSCs), also known as mesenchymal stromal cells.
  3. Hematopoietic Stem Cells (HSCs).
  4. Pancreatic Endoderm Cells.

What they were trying to find out:

1. The role of stem cells in creating pancreatic beta-like cells.
2. The effectiveness and safety of stem cell therapies for diabetes.
3. How these therapies compare to existing treatments like insulin and islet transplantation.
4. The challenges that need to be overcome for clinical use.

What they found

• Effectiveness:
  • Some studies reported notable improvements in blood sugar control, with reductions in HbA1c levels and increases in C-peptide levels.
  • Some trials found that patients had reduced insulin requirements.
  • A few patients in early-phase trials and case reports achieved insulin independence

Mechanism of Action:

• The review describes two main ways the cells work.
• Differentiation: Pluripotent stem cells are unspecialized cells that can be directed to turn into new insulin-producing beta-like cells in the pancreas, replacing the damaged ones.
• Paracrine Signaling and Immunomodulation: Mesenchymal stem cells help the body heal by sending out signals that reduce inflammation, rather than by turning into new cells. These signals create a healing environment, suppress the immune system’s attack on the pancreas, and improve insulin sensitivity.

Stem Cell Source Comparison:

• The review found that different types of stem cells were used across the trials.
• For adipose tissue-derived cells, one study found they improved basal C-peptide levels and reduced HbA1c in Type 1 diabetes patients.
• For bone marrow-derived MSCs, one study found they improved insulin sensitivity in Type 2 diabetes patients.
• Pancreatic endoderm cells were successfully used to achieve insulin independence in one patient.

Safety:

• Stem cell therapies were found to be generally safe.
• The most common side effects were mild and short-lived, such as fever, nausea, or reactions at the injection site.
• No serious adverse events or tumor formation were reported in most of the studies.

Limitations Across Trials:

• The studies reviewed varied significantly in their design, the types of stem cells used, and how they measured outcomes.
• In many cases, the positive effects were modest and often temporary.
• Improvements sometimes depended on patients also receiving other treatments, such as vitamin D or immunosuppressive drugs.
• Achieving insulin independence was not common and was mostly limited to early-phase trials.

Researchers’ Conclusions

The researchers concluded that while stem cell-derived pancreatic beta cells are being actively explored as a potential treatment for diabetes, their clinical use is still very much in its early stages.

Significant challenges remain, including achieving full cell maturity, making the treatments scalable & overcoming immune rejection.

They believe that with continued research, this field has the potential to lead to long-term, sustainable solutions for diabetes.

Conclusion: Stem Cell Research for Diabetes

Research is global, with a significant number of trials being conducted in the USA and China

Two main categories of stem cells are being explored: 

Pluripotent Stem Cells (like embryonic and iPSCs) and Mesenchymal Stem Cells (MSCs), which are often sourced from the umbilical cord and placenta.

The success of the therapy is promising, particularly for Type 1 diabetes, where multiple studies show patients achieving insulin independence.
For Type 2 diabetes, studies report improved blood sugar control, reduced insulin needs, and improved insulin sensitivity

How it works: The mechanism depends entirely on the cell type used.

• Pluripotent Stem Cells work by direct cell replacement. They are turned into new, functional insulin-producing cells that restore the pancreas’s lost function.
• Mesenchymal Stem Cells work primarily through paracrine signaling. They release signals that calm the immune system’s attack on the pancreas and reduce inflammation.

Safety is generally reported as good, with no serious side effects related to the cells themselves.

The research is still in its early stages. Many studies are limited by very small patient numbers (some are just single-patient cases), short follow-up periods and the consistent need for powerful immunosuppressant drugs.

If you’re thinking about treatment, be aware commercial clinics won’t always follow the same protocols used in these trials.

Whether it’s the way they test cells before the procedure or the manufacturing standards they follow.