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Type1diabetesPhase 1/2NCT05061030

Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents

A Phase 1/2 study testing the ATMP Protrans in people with Type1diabetes, run by Uppsala University Hospital at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a combined phase 1 and 2 study in 66 subjects, male or female, between 7-21 years of age that have recently (< 6 months) been diagnosed with type 1 diabetes. The first phase 1 part of the study includes six subjects openly receiving allogeneic Wharton's jelly derived mesenchymal stromal cells as the Advanced… Read more about this study

Who is it for?
Ages 7 to 21 years
Conditions the study is for
Type1diabetes
What is being tested?
the ATMP Protrans
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteSweden
Study dates
14 Jan 2022to Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
  • Clinical history compatible with type 1 diabetes diagnosed less than 6 months before enrolment
  • 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.
  • Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol.
  • Fasting plasma C-peptide concentration >0.12 nmol/L.
  • 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:
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  • oral (except low-dose gestagen (lynestrenol and noretisteron), injectable or implanted hormonal contraceptives.
  • intrauterine device
  • intrauterine system (for example progestin-releasing coil)
  • vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)

Who cannot join

  • Subjects with body weight >100 kg
  • Subjects with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
  • Subjects with uncontrolled hypertension (≥160/105 mmHg).
  • Subjects with active on-going infections.
  • 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.
  • 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.
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  • Subjects with any systemic immune suppressive treatment
  • Subjects with a known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease.
  • 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.
  • Subjects with known, or previous, malignancy.
  • Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin.
  • Subjects with GFR <60 ml/min/1.73 m2 body surface.
  • Subject with any condition or any circumstance that, in the opinion of the investigator, would make it unsafe to undergo treatment with MSC.
  • Known hypersensitivity against any excipients, i.e., dimethyl sulfoxide (DMSO).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala University Hospital

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: A Double-blinded, Randomized, Parallel, Placebo-controlled Trial of Wharton's Jelly-derived Allogeneic Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents

This is a combined phase 1 and 2 study in 66 subjects, male or female, between 7-21 years of age that have recently (< 6 months) been diagnosed with type 1 diabetes. The first phase 1 part of the study includes six subjects openly receiving allogeneic Wharton's jelly derived mesenchymal stromal cells as the Advanced Therapy Medicinal Product (ATMP) Protrans, three each in the age ranges 7-11 and 12-18.The second part is a randomized, double-blinded placebo-controlled phase 2 study in parallel design comparing allogeneic Wharton's jelly derived mesenchymal stromal cells treatment (as Protrans) to placebo in children and adolescent subjects (7-21 years of age) diagnosed with type 1 diabetes, The primary objectives of this study will be to investigate the safety, tolerance and efficacy after an allogieneic infusion of Wharton's jelly derived mesenchymal stromal cells.

Conditions
Type1diabetes
Being tested
the ATMP Protrans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the ATMP ProtransBiological

    Protrans consists of Wharton's jelly derived mesenchymal stromal cells

Study groups in NCT05061030
Study groupRoleWhat they receive
Wharton's jelly derived mesenchymal stromal cells (Protrans)Active comparatorCells 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).
Receives: Biological: the ATMP Protrans
PlaceboPlacebo comparatorPlacebo (saline) is given intravenously over a period of 20-40 min.
Receives: Biological: the ATMP Protrans

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety at one year evaluated as adverse events

    Safety parameters will be evaluated at each study visit and recorded as adverse events.

    Measured: One year

  2. Safety at five years evaluated as adverse events

    Safety parameters will be evaluated at each study visit and recorded as adverse events.

    Measured: Five years

  3. Efficacy measured as change in C-peptide Area under the curve to a mixed mealtolerance test.

    Change in C-peptide Area under the curve (AUC) (0-120 min) for mixed meal tolerance test (MMTT) at 12 months following Protrans/Placebo infusion when compared to test performed before the start of treatment (baseline).

    Measured: One year

Secondary outcomes (15)

  1. Insulin independency

    The proportion of study participants independent of insulin at 6 months

    Measured: One year

  2. Insulin independency

    The proportion of study participants independent of insulin at 12 months

    Measured: One year

  3. Low insulin needs

    The proportion of study participants with daily insulin needs <0.25 U/kg at 6 months

    Measured: 6 months

  4. Low insulin needs

    The proportion of study participants with daily insulin needs <0.25 U/kg at 12 months

    Measured: 12 months

  5. Insulin needs

    Insulin requirement/kg body weigh at 6 months

    Measured: 6 months

  6. Insulin needs

    Insulin requirement/kg body weigh at 12 months

    Measured: 12 months

  7. HbA1c

    HbA1c at 6 months

    Measured: 6 months

  8. HbA1c

    HbA1c at 12 months

    Measured: 12 months

  9. Time in target

    Time in target (4-8 mmol/l) as measured by flash glucose monitoring for 14 days at 6 months

    Measured: 6 months

  10. Time in target

    Time in target (4-8 mmol/l) as measured by flash glucose monitoring for 14 days at 12 months

    Measured: 12 months

  11. Time in range

    Time in target (3.9-10 mmol/l) as measured by flash glucose monitoring for 14 days at 6 months

    Measured: 6 months

  12. Time in range

    Time in target (3.9-10 mmol/l) as measured by flash glucose monitoring for 14 days at 12 months

    Measured: 12 months

  13. C-peptide

    Change in C-peptide Area under the curve (AUC) (0-120 min) for mixed meal tolerance test (MMTT) at 6 months following Protrans/Placebo infusion when compared to test performed before the start of treatment (baseline).

    Measured: 6 months

  14. Change in peak C-peptide

    Change in peak C-peptide concentration during the first 6 months

    Measured: 6 months

  15. Change in peak C-peptide

    Change in peak C-peptide concentration during the first 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start14 Jan 2022
  3. Primary completionSep 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05061030
Sponsor's protocol ID
WJMSC-P01
Status last verified
Apr 2026
First submitted
20 Sep 2021
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing the ATMP Protrans in people with Type1diabetes, run by Uppsala University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety at one year evaluated as adverse events (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05061030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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