Status:
COMPLETED
Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes
Lead Sponsor:
NextCell Pharma Ab
Conditions:
Type1 Diabetes Mellitus
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes.
Detailed Description
This is a combined phase I and phase II study, where the first part is an open, dose escalating study consisting of 9 male patients, 18-40 years of age. The second part is a randomized, double-blinded...
Eligibility Criteria
Inclusion
- Written informed consent for participation of the study, given before undergoing any study-specific procedures
- Clinical history compatible with type 1 diabetes diagnosed less than 2 years before enrolment
- In the first part of the study patients 1-9 only male patients between 18-40 years of age will be included. In the second part of the study, patients 10-24, both male and female patients 18 to 40 years of age (inclusive at both ends) will be included.
- Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol
- Fasting plasma C-peptide concentration \>0.12 nmol/L.
- 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/):
- Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contracption associated with inhibition of ovulation
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- total abstinence or vasectomized partner.
Exclusion
- Inability to provide informed consent
- Patients with body mass index (BMI) \> 30, or weight \>100 kg
- Patients with weight \<50 kg
- Patients with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
- Patients with uncontrolled hypertension (≥160/105 mmHg).
- Patients with active on-going infections.
- 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.
- 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.
- Patients with any immune suppressive treatment
- Patients with known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease-
- 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.
- Patients with known, or previous, malignancy.
- Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin.
- Patients with GFR \<80 ml/min/1.73 m2 body surface.
- Patients with proliferative retinopathy.
- Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
- Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03406585
Start Date
November 28 2017
End Date
September 4 2020
Last Update
April 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 141 86