Wharton´s jelly derived mesenchymal stromal cell treatment of adult patients diagnosed with type I diabetes.

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002766-50-SE
• Lead Sponsor: extCell Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Written informed consent for participation of the study, given before undergoing any study-specific procedures
2. Clinical history compatible with type 1 diabetes diagnosed less than 2 years before enrolment
3. In the first part of the study patients 1-6 only male patients between 18-40 years of age will be included. In the second part of the study, patients 7-21, both male and female patients 18 to 40 years of age (inclusive at both ends) will be included.
4. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol
5. Fasting plasma C-peptide concentration >0.12 nmol/L.
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. Such methods include (in Recommendations related to contraception and pregnancy testing in clinical trials”, supplied from www.hma.eu/):
a. Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.
-oral
-intravaginal
-transdermal
b. progestogen-only hormonal contracption associated with inhibition of ovulation
- oral
- injectable
- implantable
c. intrauterine device (IUD)
d. intrauterine hormone-releasing system (IUS)
e. bilateral tubal occlusion
f. total abstinence or vasectomized partner.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
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. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
14. Patients with GFR <80 ml/min/1.73 m2 body surface.
15. Patients with proliferative retinopathy
16. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
17. Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified