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Type1 Diabetes MellitusPhase 1/2NCT03406585

Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes

A Phase 1/2 study testing ProTrans: Allogeneic transplantation with WJMSCs in people with Type1 Diabetes Mellitus, run by NextCell Pharma Ab at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Type1 Diabetes Mellitus
What is being tested?
ProTrans: Allogeneic transplantation with WJMSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteSweden
Study dates
28 Nov 2017to 4 Sep 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written informed consent for participation of the study, given before undergoing any study-specific procedures
  • Clinical history compatible with type 1 diabetes diagnosed less than 2 years before enrolment
  • In the first part of the study patients 1-9 only male patients between 18-40 years of age will be included. In the second part of the study, patients 10-24, both male and female patients 18 to 40 years of age (inclusive at both ends) will be included.
  • 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.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. Such methods include (in "Recommendations related to contraception and pregnancy testing in clinical trials", supplied from www.hma.eu/):
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  • Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.
  • oral
  • intravaginal
  • transdermal
  • progestogen-only hormonal contracption associated with inhibition of ovulation
  • oral
  • injectable
  • implantable
  • intrauterine device (IUD)
  • intrauterine hormone-releasing system (IUS)
  • bilateral tubal occlusion
  • total abstinence or vasectomized partner.

Who cannot join

  • Inability to provide informed consent
  • Patients with body mass index (BMI) > 30, or weight >100 kg
  • Patients with weight <50 kg
  • Patients with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
  • Patients with uncontrolled hypertension (≥160/105 mmHg).
  • Patients with active on-going infections.
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  • Patients with latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or has travelled in areas with high risk of tuberculosis or mycosis within the last 3 months.
  • Patients with serological evidence of infection with HIV, Treponema pallidum, hepatitis B antigen (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
  • Patients with any immune suppressive treatment
  • Patients with 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.
  • Patients with known, or previous, malignancy.
  • Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin.
  • Patients with GFR <80 ml/min/1.73 m2 body surface.
  • Patients with proliferative retinopathy.
  • Patient 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

  • Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86

Other trials in Sweden

About this study

Official title: A Double-blinded, Randomized, Placebo-controlled Trial With Wharton's Jelly Derived Allogeneic Mesenchymal Stromal Cells (WJMSCs) for Preserving Endogenous Insulin Production in Adult Patients Diagnosed for Type 1 Diabetes

To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes.

Read the detailed description

This is a combined phase I and phase II study, where the first part is an open, dose escalating study consisting of 9 male patients, 18-40 years of age. The second part is a randomized, double-blinded, placebo-controlled, phase I/II study in parallel design comparing allogeneic WJMSC treatment to placebo in adult patients diagnosed with type 1 diabetes. Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed.

A total number of 24 patients will be enrolled in the study and followed for one year after WJMSC/placebo treatment. Patients 18-40 years of age, both male and female, diagnosed for type 1 diabetes will be eligible. Providing informed consent and fulfillment of inclusion criteria and no exclusion criteria, they will within two years of diagnosis be randomized.

Being tested
ProTrans: Allogeneic transplantation with WJMSCs, Placebos

What participants receive

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

  • ProTrans: Allogeneic transplantation with WJMSCsDrug

    Also called Protrans

    The drug is a cell suspension with allogeneic mesenchymal stromal cells derived from umbilical cord tissue.

  • PlacebosDrug

    Also called Placebo

    Placebo treatment

Study groups in NCT03406585
Study groupRoleWhat they receive
Allogeneic transplantation with WJMSCsExperimentalSingle infusion of 200 million cells per patient.
Receives: Drug: ProTrans: Allogeneic transplantation with WJMSCs
Sham transplantation (placebo)Placebo comparatorSingle infusion with albumin and dmso in sodium chloride (identical concentrations as active treatment)
Receives: Drug: Placebos

What is being measured

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

  1. Safety; measured through set safety parameters

    measured through the registration of adverse events and other safety parameters such as hypoglycemia, allergic reactions, ophthalmologic examination, ECG, vital signs and laboratory assessments.

    Measured: throughout the study untill day 372

  2. Efficacy; comparison of the intervention versus placebo at day 372 versus start of treatment

    Delta-change of C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at day 372 following WJMSC/Placebo infusion when compared to test performed before start of treatment.

    Measured: Day 372

Secondary outcomes (7)

  1. Number of patients insulin independent (ADA criteria) at days 187 and 372

    Insulin doses and measured plasma glucose values are written down in the subject's diary every day by the subject. Amount of insulin, recorded plasma glucose values, time and date will be included

    Measured: Days 187 and 372 following WJMSC/Placebo infusion

  2. Number of patients with daily insulin needs <0.25U/kg at days 187 and 372

    Insulin doses and measured plasma glucose values are written down in the subject's diary every day by the subject. Amount of insulin, recorded plasma glucose values, time and date will be included

    Measured: Days 187 and 372 following WJMSC/Placebo infusion

  3. Insulin requirement/kg BW at days 187 and 372

    Insulin doses and measured plasma glucose values are written down in the subject's diary every day by the subject. Amount of insulin, recorded plasma glucose values, time and date will be included

    Measured: Days 187 and 372 following WJMSC/Placebo infusion

  4. HbA1c at days 187 and 372.

    Measurements of HbA1c will be performed to assess metabolic control during study.

    Measured: Days 187 and 372 following WJMSC/Placebo infusion

  5. Glucose variability at day 372

    Measurements of HbA1c will be performed to assess metabolic control during study.

    Measured: Day 372 following WJMSC/Placebo infusion

  6. Delta change of levels of fasting C-peptide at day 372

    Measured at day 372 compared to before start of treatment

    Measured: Day 372 following WJMSC/Placebo infusion

  7. Numbers of patients with peak C-peptide >0.20 nmol/l, in response to the MMTT, at day 372

    Measured at day 372 compared to before start of treatment

    Measured: Day 372 following WJMSC/Placebo infusion

Timeline

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

  1. First posted23 Jan 2018
  2. Study start28 Nov 2017
  3. Primary completion1 Jul 2020
  4. Study completion4 Sep 2020

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406585
Sponsor's protocol ID
ProTrans-T1D
Other IDs
2017-002766-50, 2017
Status last verified
Mar 2023
First submitted
27 Nov 2017
Last updated
3 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carlsson PO, Espes D, Sisay S, Davies LC, Smith CIE, Svahn MG. Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial. Diabetologia. 2023 Aug;66(8):1431-1441. doi: 10.1007/s00125-023-05934-3. Epub 2023 May 24.

    PubMed 37221247

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ProTrans: Allogeneic transplantation with WJMSCs in people with Type1 Diabetes Mellitus, run by NextCell Pharma Ab 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 18 inclusion and 17 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: finished, as of the sponsor's last update on 3 Apr 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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; measured through set safety parameters (time frame: throughout the study untill day 372). The study lists 2 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 NCT03406585, which also lists 1 linked publication.

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 3 Apr 2023.

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