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

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What is this study about?

This clinical trial is focused on studying Type 1 diabetes in children and adolescents. The treatment being tested is called ProTrans, which is a type of cell therapy. It is given as a suspension through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to investigate the safety, tolerance, and effectiveness of this treatment in young people who have been diagnosed with Type 1 diabetes within the last six months.

Participants in the study will receive either the ProTrans treatment or a placebo. The study is designed to be double-blinded, which means neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations. The study will be conducted in two parts, with the first part involving a small group of participants to assess initial safety, followed by a larger group in the second part. The study will monitor participants over a period of time to evaluate how well the treatment works and to check for any side effects.

Throughout the study, various health parameters will be measured, such as insulin needs and blood sugar levels, to determine the treatment’s impact on managing Type 1 diabetes. The study aims to see if the treatment can help reduce the need for insulin and improve blood sugar control. Participants will be closely monitored for any adverse events, and the study will assess changes in specific markers related to diabetes management over time.

1 enrollment

Participation begins after providing written informed consent. For those under 18, consent is also required from caregivers.

Eligibility includes a diagnosis of type 1 diabetes within the last 6 months, and a fasting plasma C-peptide concentration greater than 0.12 nmol/L.

2 initial assessment

An initial assessment is conducted to confirm eligibility and establish baseline health metrics.

Participants are stratified by age and randomized into either the active treatment group or the placebo group.

3 treatment administration

The treatment involves an intravenous infusion of ProTrans, a suspension for IV infusion.

The infusion is administered under medical supervision to ensure safety and monitor any immediate reactions.

4 follow-up visits

Regular follow-up visits are scheduled to monitor safety and efficacy.

Safety is assessed by recording any adverse events, with particular attention to any severe reactions.

5 efficacy evaluation

Efficacy is evaluated by measuring changes in C-peptide levels during a Mixed Meal Tolerance Test (MMTT) at 6 and 12 months.

Additional assessments include insulin independence, daily insulin needs, and glycosylated hemoglobin (HbA1c) levels.

6 completion

The trial concludes with a final assessment to evaluate long-term outcomes and any lasting effects of the treatment.

Participants are informed of their treatment group and provided with a summary of their health outcomes.

Who Can Join the Study?

  • Provide written informed consent to participate in the study. If you are under 18, both of your caregivers must also give their consent.
  • Have a clinical history that matches with type 1 diabetes diagnosed less than 6 months before joining the study.
  • Be within the age range specified for the study. In the first part, six participants aged 7-11 and 12-18 will be included. In the second part, participants aged 7-11 and 12-21 will be included and randomly assigned to one of two treatment groups.
  • Be mentally stable and, in the opinion of the study doctor, able to follow the study procedures.
  • Have a fasting plasma C-peptide concentration greater than 0.12 nmol/L. C-peptide is a substance made in the pancreas, and its level can help understand how much insulin your body is making.
  • If you can have children, you must agree to use adequate birth control until one year after receiving the study treatment or placebo. Adequate birth control includes:
    • Oral hormonal contraceptives (except low-dose types), injections, or implants.
    • Intrauterine device (IUD).
    • Intrauterine system, like a progestin-releasing coil.
    • Having a male partner who has had a vasectomy, which is a procedure to prevent sperm from being in the semen.

Who Cannot Join the Study?

  • Patients who have had type 1 diabetes for more than 6 months cannot participate.
  • Patients who are not children or adolescents are excluded.
  • Patients with any other serious health conditions that might interfere with the study are not eligible.
  • Patients who have received other treatments that could affect the study results are excluded.
  • Patients who are unable to follow the study procedures or attend follow-up visits cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients with a history of allergic reactions to similar treatments are excluded.
  • Patients who are part of another clinical trial at the same time are not eligible.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Region Skane Skanes Universitetssjukhus Lund Sweden
Uvtmhdo Uwemncuvko Hdkgdvlc Uppsala Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.01.2021

Trial locations

Investigated drugs:

Wharton’s Jelly-derived Allogenic Mesenchymal Stromal Cells (WJMSC-P01) are being studied for their potential to treat Type 1 Diabetes in children and adolescents. These cells are derived from Wharton’s Jelly, a substance found in the umbilical cord, and are used in this trial to see if they can help improve the body’s ability to manage blood sugar levels. The goal is to determine if these cells can be safely and effectively infused into patients to help manage their diabetes.

Investigated diseases:

Type 1 diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in children and adolescents but can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. This leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, nerves, eyes, and kidneys. The exact cause of this immune response is unknown, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:
2024-518270-14-00
Protocol code:
WJMSC-P01
NCT ID:
NCT05061030
Trial Phase:
Therapeutic exploratory (Phase II)

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