Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents
NCT ID: NCT05061030
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2022-01-14
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Wharton's jelly derived mesenchymal stromal cells (Protrans)
Cells are dissolved in saline and given intravenously over a period of 20-40 min. 100 million cells to subjects \< 50 kg and 200 million cells to subjects 50-100 kg (\>100 kg is an exclusion criterion).
the ATMP Protrans
Protrans consists of Wharton's jelly derived mesenchymal stromal cells
Placebo
Placebo (saline) is given intravenously over a period of 20-40 min.
the ATMP Protrans
Protrans consists of Wharton's jelly derived mesenchymal stromal cells
Interventions
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the ATMP Protrans
Protrans consists of Wharton's jelly derived mesenchymal stromal cells
Eligibility Criteria
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Inclusion Criteria
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
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).
7 Years
21 Years
ALL
No
Sponsors
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Uppsala University Hospital
OTHER
Responsible Party
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Per-Ola Carlsson
Professor, Senior consultant in Endocrinology and Diabetology
Principal Investigators
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Per-Ola Carlsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Locations
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Uppsala University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Per-Ola Carlsson, MD, PhD
Role: primary
Other Identifiers
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WJMSC-P01
Identifier Type: -
Identifier Source: org_study_id