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

• Status: Recruiting
• Trial end date: 2024-10-17
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NextCell Pharma Ab

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 infections unless treatment is not judged necessary by the investigators

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).