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Protrans

ProTrans, a groundbreaking cell therapy derived from Wharton’s Jelly Mesenchymal Stromal Cells (WJMSCs), is being studied in clinical trials for its potential to preserve insulin production in adults with Type 1 Diabetes. These trials aim to evaluate the safety, efficacy, and impact of ProTrans on patients’ insulin requirements and overall diabetes management.

Table of Contents

What is ProTrans?

ProTrans is an innovative medical treatment being developed for Type 1 Diabetes. It is a cell-based therapy that uses special cells called Wharton’s Jelly-derived Mesenchymal Stromal Cells (WJMSCs)[1]. These cells are obtained from the umbilical cord tissue, which is rich in healing and regenerative properties.

ProTrans is also known by other names, including:

  • Allogeneic transplantation with WJMSCs[1]
  • Wharton’s Jelly Derived Mesenchymal Stromal Cell treatment[2]

How ProTrans Works

ProTrans is designed to help preserve the body’s ability to produce insulin in patients with Type 1 Diabetes. In this condition, the body’s immune system mistakenly attacks and destroys the insulin-producing cells in the pancreas. ProTrans aims to:

  • Protect remaining insulin-producing cells
  • Potentially regenerate damaged cells
  • Modulate the immune system to prevent further damage

The treatment involves a single infusion of these special cells directly into the patient’s bloodstream. The number of cells used can vary, with researchers testing different doses to find the most effective treatment[1].

Clinical Trials of ProTrans

ProTrans is currently being studied in clinical trials to determine its safety and effectiveness. Two main studies are underway:

  1. Repeated Treatment Study: This is a Phase I/II study involving 18 adult male patients aged 18-41 who have been diagnosed with Type 1 Diabetes for less than 3.5 years. The study aims to test different doses of ProTrans and evaluate its safety and effects on insulin production[1].
  2. Double-Blinded Study: This is a combined Phase I and II study involving 24 patients aged 18-40, both male and female. It compares ProTrans treatment to a placebo to assess its safety and effectiveness in preserving insulin production[2].

Potential Benefits of ProTrans

The clinical trials are investigating several potential benefits of ProTrans, including:

  • Preserved insulin production: Measured by C-peptide levels, which indicate how much insulin the body is producing[1][2]
  • Reduced insulin requirements: Some patients might need less external insulin or potentially become insulin-independent[1][2]
  • Improved blood sugar control: Measured by HbA1c levels and glucose variability[1][2]
  • Enhanced quality of life: Assessed through diabetes treatment satisfaction questionnaires[2]

Safety Considerations

The primary focus of these clinical trials is to ensure the safety of ProTrans. Researchers are closely monitoring:

  • Adverse events
  • Hypoglycemia (low blood sugar) episodes
  • Allergic reactions
  • Changes in vital signs and laboratory tests
  • Effects on the eyes (through ophthalmologic examination)
  • Heart function (through ECG)[1][2]

Future Prospects

If ProTrans proves to be safe and effective in these clinical trials, it could potentially revolutionize the treatment of Type 1 Diabetes. Some exciting possibilities include:

  • Reducing or eliminating the need for daily insulin injections
  • Improving long-term health outcomes for people with Type 1 Diabetes
  • Offering a new approach to managing autoimmune diseases

However, it’s important to note that ProTrans is still in the experimental stage. More research is needed to fully understand its benefits and potential risks before it can be widely available as a treatment option[1][2].

Aspect Details
Treatment ProTrans (Wharton’s Jelly Mesenchymal Stromal Cells)
Condition Type 1 Diabetes in adults
Administration Single intravenous infusion
Dosage 25 million to 200 million cells per patient
Primary Outcomes Safety, changes in C-peptide levels
Secondary Outcomes Insulin requirements, HbA1c, glucose variability
Study Duration One year follow-up
Key Assessment Points Day 187 and Day 372 after infusion

FAQ

  • What is ProTrans? ProTrans is a cell therapy made from Wharton's Jelly Mesenchymal Stromal Cells (WJMSCs), which are derived from umbilical cord tissue. It is being studied as a potential treatment for Type 1 Diabetes to help preserve the body's ability to produce insulin.
  • How is ProTrans administered in the clinical trials? In the clinical trials, ProTrans is administered as a single infusion of cells. The dosage varies depending on the study, ranging from 25 million to 200 million cells per patient.
  • What are the main goals of the ProTrans clinical trials? The main goals are to assess the safety and tolerance of ProTrans in adults with Type 1 Diabetes, and to study its effects on preserving insulin production, reducing insulin requirements, improving blood sugar control, and enhancing overall diabetes management.
  • How long do the ProTrans clinical trials last? The clinical trials typically follow patients for one year after receiving the ProTrans treatment or placebo. Key assessments are made at various time points, with major evaluations occurring at day 372 (approximately one year) after the infusion.
  • What are some of the outcomes being measured in these trials? The trials measure several outcomes, including changes in C-peptide levels (an indicator of insulin production), daily insulin requirements, HbA1c levels (a measure of long-term blood sugar control), glucose variability, and the number of patients who become insulin-independent or require very low insulin doses.

Ongoing Clinical Trials on Protrans

  • Study on the Safety and Effectiveness of ProTrans for Treating Type 1 Diabetes in Children and Adolescents

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

Glossary

  • Wharton's Jelly Mesenchymal Stromal Cells (WJMSCs): Special cells derived from the soft, gel-like tissue found in the umbilical cord. These cells have the potential to develop into different types of cells and are being studied for their therapeutic properties.
  • C-peptide: A substance produced along with insulin. Measuring C-peptide levels helps determine how much insulin the body is producing on its own.
  • HbA1c: Also known as glycated hemoglobin, this is a blood test that shows average blood sugar levels over the past 2-3 months. It's an important measure of long-term blood sugar control in diabetes management.
  • Mixed Meal Tolerance Test (MMTT): A test used to assess how well the body produces insulin in response to food. It involves drinking a special liquid meal and measuring blood sugar and C-peptide levels over time.
  • Glucose variability: The degree to which a person's blood sugar levels fluctuate throughout the day. Lower variability is generally associated with better diabetes control.
  • Allogeneic: Referring to cells or tissue that come from a genetically different donor of the same species. In this case, the WJMSCs used in ProTrans come from donated umbilical cord tissue, not the patient's own cells.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs. In these trials, some patients receive a placebo infusion that looks like ProTrans but doesn't contain active cells.
  • Type 1 Diabetes: An autoimmune condition where the body's immune system attacks and destroys insulin-producing cells in the pancreas, leading to little or no insulin production and the need for lifelong insulin therapy.

References

  1. https://clinicaltrials.gov/study/NCT03973827
  2. https://clinicaltrials.gov/study/NCT03406585