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

NCT ID: NCT03973827

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-17
• Study Completion Date: 2024-11-20

Brief 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.

Conditions

Type1diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose

3 patients receiving low dose

Group Type: EXPERIMENTAL

ProTrans

Intervention Type: DRUG

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

Medium dose

3 patients receiving medium dose

Group Type: EXPERIMENTAL

ProTrans

Intervention Type: DRUG

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

High dose

3 patients receiving high dose

Group Type: EXPERIMENTAL

ProTrans

Intervention Type: DRUG

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

Control

6 patients

Group Type: OTHER

Control

Intervention Type: OTHER

No intervention. Control subjects.

Interventions

ProTrans

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

Intervention Type: DRUG

Control

No intervention. Control subjects.

Intervention Type: OTHER

Other Intervention Names

Allogeneic transplantation with WJMSCs

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

NextCell Pharma Ab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per-Ola Carlsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge

Huddinge, , Sweden

Countries

Sweden

Other Identifiers

2018-004158-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ProTrans-Repeat

Identifier Type: -

Identifier Source: org_study_id