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Wharton´s Jelly Derived Mesenchymal Stromal Cell Repeated Treatment of Adult Patients Diagnosed with Type I Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT03973827•NextCell Pharma Ab

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - 41 years

Sex

MALE

Healthy Volunteers

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

•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.
+6 more criteria

Locations (1)

Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge

Huddinge, Sweden

Key Dates

Start Date

May 17, 2019

Primary Completion Date

December 10, 2020

Completion Date

November 20, 2024

Last Updated

March 7, 2025

Enrollment

ACTUAL participants

Conditions

Type1diabetes

Interventions

ProTrans

DRUG

Control

OTHER

Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children

NCT05054361

Type1diabetes

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RECRUITINGPHASE1

Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors

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DiabetesType1diabetes+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children

Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors

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

Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus

Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Advanced Glycation Products and Vascular Complications in Type 1 Diabetes