Could stem cells help kids with New-Onset diabetes?
NCT ID NCT05061030
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a single infusion of stem cells from donated umbilical cord tissue (Wharton's jelly) in 66 children and teens aged 7–21 who were diagnosed with type 1 diabetes within the last 6 months. The goal is to see if the treatment is safe and can help the body produce more insulin, reducing the need for daily insulin shots. Participants are randomly assigned to receive either the stem cells or a placebo, and neither they nor their doctors will know which they received.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent for participation of the study (for subjects below 18 years of age also from both caregivers), given before undergoing any study-specific procedures 2. Clinical history compatible with type 1 diabetes diagnosed less than 6 months before enrolment 3. In the first part of the study, six subjects, three between 7-11 and three between 12-18 years of age (both groups inclusive at both ends), will be included. The sixty subjects in the second part of the study are stratified by age (12-21 and 7-11 years, respectively) and randomized to one of two treatment arms (active or placebo), with a 6-month safety delay for the younger stratum. 4. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol. 5. Fasting plasma C-peptide concentration \>0.12 nmol/L. 6. Subjects of child-bearing potential must agree to using adequate contraception until one year after the administration of WJMSC/Placebo. Adequate contraception is as follows: 1. oral (except low-dose gestagen (lynestrenol and noretisteron), injectable or implanted hormonal contraceptives. 2. intrauterine device 3. intrauterine system (for example progestin-releasing coil) 4. vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate) Exclusion Criteria: 1. Subjects with body weight \>100 kg 2. Subjects with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris. 3. Subjects with uncontrolled hypertension (≥160/105 mmHg). 4. Subjects with active on-going infections. 5. Subjects with latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or has traveled in areas with a high risk of tuberculosis or mycosis within the last 3 months. 6. Subjects with serological evidence of infection with HIV, Treponema pallidum, hepatitis B antigen (subjects with serology consistent with previous vaccination and a history of vaccination are acceptable), or hepatitis C. 7. Subjects with any systemic immune suppressive treatment 8. Subjects with a known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease. 9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 10. Subjects with known, or previous, malignancy. 11. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin. 12. Subjects with GFR \<60 ml/min/1.73 m2 body surface. 13. Subject with any condition or any circumstance that, in the opinion of the investigator, would make it unsafe to undergo treatment with MSC. 14. Known hypersensitivity against any excipients, i.e., dimethyl sulfoxide (DMSO).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Uppsala University Hospital
Uppsala, 75185, Sweden
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Other studies related to the condition(s) this trial covers.
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