CClinicalTrials.gg
Sign In
CompletedNCT03973827Updated Mar 7, 2025

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

A Phase 1/2 interventional study of ProTrans and Control in Type1diabetes, sponsored by NextCell Pharma Ab. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by NextCell Pharma Ab · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 41 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Type1diabetes

Keywords

  • type 1 diabetes
  • diabetes
  • MSC's
  • Mesenchymal
  • Stem Cells
  • Stromal
  • Wharton´s Jelly
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 15 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

NextCell Pharma Ab is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 41 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. A new written informed consent for participation of the study is required to be given before undergoing any study-specific procedures.
  2. Only patients that have previously been dosed by the IMP according to protocol Protrans-1 are eligible for a second dose of Protrans.
  3. 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.
  4. Clinical history compatible with type 1 diabetes diagnosed less than 3 years before enrolment. This also includes control patients not receiving IMP.
  5. Only male patients between 18-41 years of age will be included.
  6. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Patients with body mass index (BMI) > 30, or weight >100 kg
  3. Patients with weight \<50 kg
  4. Patients with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
  5. Patients with uncontrolled hypertension (≥160/105 mmHg).
  6. Patients with active on-going infections.
  7. 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.
  8. 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.
  9. Patients with any immune suppressive treatment
  10. Patients with known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease.
  11. Patients with known, or previous, malignancy.
  12. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
  13. Patients with GFR \<80 ml/min/1.73 m2 body surface
  14. Patients with proliferative retinopathy
  15. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
  16. Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).- This criterion is only applicable to patients which receive study drug.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Low dose

    3 patients receiving low dose

    Drug: ProTrans

  • Experimental
    Medium dose

    3 patients receiving medium dose

    Drug: ProTrans

  • Experimental
    High dose

    3 patients receiving high dose

    Drug: ProTrans

  • Other
    Control

    6 patients

    Other: Control

Interventions

  • DrugProTrans

    Single infusion of 25, 100 or 200 million cells per patient.

    Also known as: Allogeneic transplantation with WJMSCs

  • OtherControl

    No intervention. Control subjects.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 372 days

  2. 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 .

    Time frame: 372 days

Secondary outcomes

  1. Number of patients insulin independent (ADA criteria) at day 372.

    To study changes in insulin requirements during one year following treatment .

    Time frame: 372 days

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

    To study changes in insulin requirements during one year following treatment .

    Time frame: 372 days

  3. Insulin requirement/kg BW at day 372. HbA1c at day 372.

    To study changes in insulin requirements during one year following treatment .

    Time frame: 372 days

  4. HbA1c at day 372

    To study changes in HbA1c during one year following treatment.

    Time frame: 372 days

  5. 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.

    Time frame: 372 days

  6. 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.

    Time frame: 372 days

  7. 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.

    Time frame: 372 days

  8. 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.

    Time frame: 372 days

  9. To study changes in insulin requirements during one year following treatment

    2. 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:

    Time frame: 372 days

07

Study locations

1 site
  • Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge
    Huddinge, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03973827
Lead sponsor
NextCell Pharma Ab
Responsible party
Sponsor
First posted
Jun 4, 2019
Start date
May 17, 2019
Primary completion
Dec 10, 2020
Completion
Nov 20, 2024
Last update
Mar 7, 2025

Study contacts

Per-Ola Carlsson, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

NextCell Pharma Ab

Start the discussion