Type1diabetesPhase 1/2NCT03973827
Wharton´s Jelly Derived Mesenchymal Stromal Cell Repeated Treatment of Adult Patients Diagnosed with Type I Diabetes
A Phase 1/2 study testing ProTrans in people with Type1diabetes, run by NextCell Pharma Ab at 1 site in Sweden.
Trial summary
An open label, parallel single centre trial of Wharton's Jelly derived allogenic mesenchymal stromal cells repeated treatment to preserve endogenous insulin production in adult patients diagnosed with type 1 diabetes Read more about this study
- Who is it for?
- Ages 18 to 41 years, men only
- Conditions the study is for
- Type1diabetes
- What is being tested?
- ProTrans
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 17 May 2019to 20 Nov 2024
- 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 41 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- A new written informed consent for participation of the study is required to be given before undergoing any study-specific procedures.
- Only patients that have previously been dosed by the IMP according to protocol Protrans-1 are eligible for a second dose of Protrans.
- No identified IMP related on-going adverse event, neither history of any adverse event that is evaluated potentially to be related to the previous IMP dosing in Protrans I.
- Clinical history compatible with type 1 diabetes diagnosed less than 3 years before enrolment. This also includes control patients not receiving IMP.
- Only male patients between 18-41 years of age will be included.
- Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol.
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.
Show all 16Show fewer
- 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.
- 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).- This criterion is only applicable to patients which receive study drug.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge
Huddinge
About this study
Official title: An Open Label, Parallel Single Centre Trial of Wharton's Jelly Derived Allogeneic Mesenchymal Stromal Cells Repeated Treatment to Preserve Endogenous Insulin Production in Adult Patients Diagnosed with Type 1 Diabetes
An open label, parallel single centre trial of Wharton's Jelly derived allogenic mesenchymal stromal cells repeated treatment to preserve endogenous insulin production in adult patients diagnosed with type 1 diabetes
Read the detailed description
This is a phase (I)/II study, and the purpose of this study is to determine whether, in adult patients diagnosed for type 1 diabetes, a repeated allogeneic infusion of WJMSCs is safe and to study changes in beta-cell function, metabolic control and Diabetes Treatment Satisfaction. The study population will consist of 15 adult male patients, 18-41 years of age (inclusive at both ends) diagnosed (<3,5 years) with type 1 diabetes mellitus.
- Conditions
- Type1diabetes
- Being tested
- ProTrans, Control
- Keywords
- type 1 diabetes, diabetes, MSC's, Mesenchymal, Stem Cells, Stromal, Wharton´s Jelly
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTransDrug
Also called Allogeneic transplantation with WJMSCs
Single infusion of 25, 100 or 200 million cells per patient.
ControlOther
No intervention. Control subjects.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 3 patients receiving low dose Receives: Drug: ProTrans |
| Medium dose | Experimental | 3 patients receiving medium dose Receives: Drug: ProTrans |
| High dose | Experimental | 3 patients receiving high dose Receives: Drug: ProTrans |
| Control | Other | 6 patients Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in this study is; safety parameters include adverse events and hypoglycemia, allergic reactions, ophthalmologic examination, ECG, vital signs, laboratory assessments.
To investigate the safety and tolerance after a repeated allogeneic infusion of Whartons Jelly Mesenchymal Stromal Cells (WJMSCs) intravenously in adult patients diagnosed with type 1 diabetes after one year following the repeated treatment.
Measured: 372 days
Delta-change of C-peptide AreaUnder the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at day 372 following WJMSC infusion when compared to test performed before start of treatment when compared to control patients.
To study changes in insulin requirements during one year following treatment .
Measured: 372 days
Secondary outcomes (9)
Number of patients insulin independent (ADA criteria) at day 372.
To study changes in insulin requirements during one year following treatment .
Measured: 372 days
Number of patients with daily insulin needs <0.25U/kg at day 372.
To study changes in insulin requirements during one year following treatment .
Measured: 372 days
Insulin requirement/kg BW at day 372. HbA1c at day 372.
To study changes in insulin requirements during one year following treatment .
Measured: 372 days
HbA1c at day 372
To study changes in HbA1c during one year following treatment.
Measured: 372 days
Glucose variability (mean amplitude of glycaemic excursions and glycaemic lability index) duration derived from the continuous glucose monitoring system® at day 372
To study changes in glucose levels during one year following treatment.
Measured: 372 days
Delta change of levels of fasting C-peptide at day 372 when compared to test before start of treatment
To study changes in fasting C-peptide levels during one year following treatment.
Measured: 372 days
Numbers of patients with peak C-peptide >0.20 nmol/l, in response to the MMTT, at day 372.
To study changes in C-peptide levels during one year following treatment.
Measured: 372 days
To study changes during one year following treatment in: -Insulin doses -HbA1c -Glucose variability -Diabetes Treatment Satisfaction
To study changes in C-peptide levels during one year following treatment.
Measured: 372 days
To study changes in insulin requirements during one year following treatment
- Delta-change of C-peptide AreaUnder the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at day 372 following WJMSC infusion when compared to test performed before start of treatment when compared to control patients.
Description:
Measured: 372 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start17 May 2019
- Primary completion10 Dec 2020
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextCell Pharma Ab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per-Ola Carlsson, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973827
- Sponsor's protocol ID
- ProTrans-Repeat
- Other IDs
- 2018-004158-11, 2018
- Status last verified
- Mar 2025
- First submitted
- 16 May 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Parallel Single Centre Trial of Wharton's Jelly Derived Allogeneic Mesenchymal Stromal Cells Repeated Treatment to Preserve Endogenous Insulin Production in Adult Patients Diagnosed with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03973827
- Acronym / sponsor ID
- ProTrans-Repeat
- Conditions
- Type1diabetes
- Keywords
- type 1 diabetes, diabetes, MSC's, Mesenchymal, Stem Cells, Stromal, Wharton´s Jelly
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NextCell Pharma AbIndustry (pharma, biotech, devices)
- Study start
- 17 May 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, parallel single centre trial of Wharton's Jelly derived allogenic mesenchymal stromal cells repeated treatment to preserve endogenous insulin production in adult patients diagnosed with type 1 diabetes
Detailed description
This is a phase (I)/II study, and the purpose of this study is to determine whether, in adult patients diagnosed for type 1 diabetes, a repeated allogeneic infusion of WJMSCs is safe and to study changes in beta-cell function, metabolic control and Diabetes Treatment Satisfaction. The study population will consist of 15 adult male patients, 18-41 years of age (inclusive at both ends) diagnosed (<3,5 years) with type 1 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: ProTrans3 patients receiving low dose |
| Medium dose | Experimental | Drug: ProTrans3 patients receiving medium dose |
| High dose | Experimental | Drug: ProTrans3 patients receiving high dose |
| Control | Other | Other: Control6 patients |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A new written informed consent for participation of the study is required to be given before undergoing any study-specific procedures.
- Only patients that have previously been dosed by the IMP according to protocol Protrans-1 are eligible for a second dose of Protrans.
- No identified IMP related on-going adverse event, neither history of any adverse event that is evaluated potentially to be related to the previous IMP dosing in Protrans I.
- Clinical history compatible with type 1 diabetes diagnosed less than 3 years before enrolment. This also includes control patients not receiving IMP.
- Only male patients between 18-41 years of age will be included.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProTransAlso: Allogeneic transplantation with WJMSCsSingle infusion of 25, 100 or 200 million cells per patient. | Drug | High dose, Low dose, Medium dose |
| ControlNo intervention. Control subjects. | Other | Control |
Primary outcome
The primary endpoint in this study is; safety parameters include adverse events and hypoglycemia, allergic reactions, ophthalmologic examination, ECG, vital signs, laboratory assessments.
Time frame: 372 days
To investigate the safety and tolerance after a repeated allogeneic infusion of Whartons Jelly Mesenchymal Stromal Cells (WJMSCs) intravenously in adult patients diagnosed with type 1 diabetes after one year following the repeated treatment.
Delta-change of C-peptide AreaUnder the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at day 372 following WJMSC infusion when compared to test performed before start of treatment when compared to control patients.
Time frame: 372 days
To study changes in insulin requirements during one year following treatment .
9 secondary outcomes
Number of patients insulin independent (ADA criteria) at day 372.
Time frame: 372 days
Number of patients with daily insulin needs <0.25U/kg at day 372.
Time frame: 372 days
Insulin requirement/kg BW at day 372. HbA1c at day 372.
Time frame: 372 days
HbA1c at day 372
Time frame: 372 days
Glucose variability (mean amplitude of glycaemic excursions and glycaemic lability index) duration derived from the continuous glucose monitoring system® at day 372
Time frame: 372 days
Delta change of levels of fasting C-peptide at day 372 when compared to test before start of treatment
Time frame: 372 days
Numbers of patients with peak C-peptide >0.20 nmol/l, in response to the MMTT, at day 372.
Time frame: 372 days
To study changes during one year following treatment in: -Insulin doses -HbA1c -Glucose variability -Diabetes Treatment Satisfaction
Time frame: 372 days
To study changes in insulin requirements during one year following treatment
Time frame: 372 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Type1diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Recruiting
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Non-Nutritive Sweetener, Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per-Ola Carlsson, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ProTrans in people with Type1diabetes, 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 6 inclusion and 16 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 7 Mar 2025. 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. 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?
The primary endpoint in this study is; safety parameters include adverse events and hypoglycemia, allergic reactions, ophthalmologic examination, ECG, vital signs, laboratory assessments. (time frame: 372 days). 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?
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 7 Mar 2025.