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Tests treatment safety and results for Type1diabetes
Official title First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06239636
What this study is testing
What is UP421?
UP421 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for type1diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The current study tests the hypothesis whether genetically modified Langerhans islet cells containing insulin-producing cells from a deceased organ donor can 1. be transplanted safely and 2.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 45
You may be able to join if
- Signed informed consent for participation in the study
- Diagnosis of type 1 diabetes mellitus (T1D); i) for ≥ 5 years and ii) diagnosed before the age of 18 years and iii) at least one or more HbA1c...
- The subject must be involved in intensive diabetes management defined as self-monitoring of subcutaneous glucose level by continuous glucose...
- C-peptide negative (C-peptide \< 0.01 nmol/l) in response to a mixed meal tolerance test (MMTT)
- Positive for antibodies to either GAD or IA2 at screening
You likely can't join if
- Any previous organ transplantation;
- 2\. Any systemic immunosuppressive medication for any other disease;
- 3\. Any history of malignancy;
- 4\. Use of any investigational agent(s) within 4 weeks of enrollment;
- 5\. Use of any anti-diabetic medication, other than insulin, within 4 weeks of enrollment;
- 6\. Active infections including Tuberculosis, HIV, HBV and HCV;
See the full eligibility criteria
- Signed informed consent for participation in the study
- Diagnosis of type 1 diabetes mellitus (T1D); i) for ≥ 5 years and ii) diagnosed before the age of 18 years and iii) at least one or more HbA1c documented in the subject's medical journal or Swedish National Diabetes...
- The subject must be involved in intensive diabetes management defined as self-monitoring of subcutaneous glucose level by continuous glucose monitoring or by intermittent scanning glucose monitoring no less than a mean...
- C-peptide negative (C-peptide \< 0.01 nmol/l) in response to a mixed meal tolerance test (MMTT)
- Positive for antibodies to either GAD or IA2 at screening
- 30-45 years of age at time of enrollment
- HbA1c ≥70 mmol/mol
- Exogenous insulin needs \< 1 IU/kg
- Body weight \<80 kg
- Female people of child-bearing potential must agree to using adequate contraception until one year after the administration of UP421, as outlined in...
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion f) vasectomised partner g) sexual abstinence Male people must not intend to procreate until one year after the administration of UP241. Males must be willing to use effective measures of...
- Any previous organ transplantation;
- 2\. Any systemic immunosuppressive medication for any other disease;
- 3\. Any history of malignancy;
- 4\. Use of any investigational agent(s) within 4 weeks of enrollment;
- 5\. Use of any anti-diabetic medication, other than insulin, within 4 weeks of enrollment;
- 6\. Active infections including Tuberculosis, HIV, HBV and HCV;
- 7\. Liver function test value for AST, ALT, GGT or ALP exceeding the respective reference interval for the clinical assay at Uppsala university hospital;
- 8\. Serological evidence of infection with HTLVI or HTLVII;
- 9\. Pregnancy, nursing, intention for pregnancy;
- 10\. Chronic kidney disease grade 3 or worse (GFR\<60 ml/min as estimated by creatine measurement) ;
- 11\. Medical history of cardiac disease, or symptoms at screening consistent with cardiac disease;
- 12\. HLA immunization;
- 13\. MIC A/B immunization;
- 14\. Known autoimmune disease other than type I diabetes (e.g. Hashimoto disease);
- 15\. Administration of live attenuated vaccines \<6 months before transplant;
- 16\. Islet antibodies where GADA \>2000 IE/ml or IA2A \>4000 IE/ml, or positive for ZnT8 auto-antibodies;
- 17\. Untreated proliferative diabetic retinopathy;
- 18\. Major ongoing psychiatric illness which the Principal Investigator judges increases the risk of noncompliance or does not allow safe participation in the study;
- 19\. Ongoing substance abuse, drug or alcohol; or recent history of treatment noncompliance;
- 20\. Known hypersensitivity to ciprofloxacin, gentamicin, or amphotericin (since these are used in the manufacturing process of UP421);
- 21\. Any other condition that in the opinion of the Principal Investigator does not allow safe participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.