PKX-001 for Type 1 Diabetes
Recruiting in Palo Alto (17 mi)
Overseen byJames Shapiro, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Alberta
Must not be taking: Steroids, Anticoagulants
Disqualifiers: Cardiac disease, Substance abuse, Psychiatric disorder, Active infection, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial tests a new drug, PKX-001, to help insulin-producing cells survive and function better when transplanted into people with hard-to-control Type 1 Diabetes. The drug protects the cells from damage and helps them produce insulin. The study aims to confirm the safety and effectiveness of this approach.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on steroids or certain anticoagulants like coumadin, you may not be eligible to participate.
What data supports the effectiveness of the drug PKX-001 for Type 1 Diabetes?
Eligibility Criteria
This trial is for people over 18 and under 68 with Type 1 Diabetes who've had it for more than 5 years, have trouble sensing low blood sugar or unstable blood sugar levels despite using insulin. They must understand the study's risks, agree to not get pregnant or father a child, and can't have certain diseases like uncontrolled thyroid issues or infections.Inclusion Criteria
I am following the specific immunosuppression regimen for islet transplant at the University of Alberta Hospital.
I have had type 1 diabetes for over 5 years.
I often don't notice when my blood sugar is too low, despite using insulin carefully.
See 1 more
Exclusion Criteria
You have a body mass index (BMI) higher than 35 at the screening visit.
You have a history of having a lot of a certain protein in your urine.
I am suspected to have rapidly worsening kidney problems.
See 21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Islet Transplantation
Participants receive allogeneic islet cells transplanted intraportally with PKX-001 treated islets
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after transplantation
3 months
Standard of care visits
Long-term Follow-up
Participants are monitored for adverse events and insulin independence up to 1 year post-transplant
Up to 1 year
Treatment Details
Interventions
- Antiaging Glycopeptide (Other)
Trial OverviewThe trial tests if PKX-001 treated islet cells (insulin-producing cells) from donors can survive better when transplanted into patients' livers. This drug mimics antifreeze proteins to protect cells during transplant against damage from immune system drugs that prevent rejection.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
PKX-001 will be supplemented to islet preservation CMRL-1066 medium at final concentration of 3 mg/mL during islet isolation process. On the day of transplantation, preserved islets supplemented with PKX-001 are collected and washed with Transplant Media, which does not contain PKX-001, as a standard procedure. The isolation team will evaluate the final islet product based on standard assays. Islets are maintained for minimal 6 hours up to 72 hours in supplemented CMRL1066-based media containing PKX-001 until the time of transplant. When product release minimal criteria are met, islets will be clinically transplanted into patients intraportally.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
ProtoKinetix Inc.Collaborator
References
Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes. [2022]Label="OBJECTIVE">A pilot study suggested that combination therapy with low-dose anti-thymocyte globulin (ATG) and pegylated granulocyte colony-stimulating factor (GCSF) preserves C-peptide in established type 1 diabetes (T1D) (duration 4 months to 2 years). We hypothesized that 1) low-dose ATG/GCSF or 2) low-dose ATG alone would slow the decline of β-cell function in patients with new-onset T1D (duration <100 days).
INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). [2022]β-cell stress and dysfunction may contribute to islet autoimmunity and progression to clinical type 1 diabetes. We present a protocol of three randomised controlled trials assessing the effects of glucagon-like peptide 1 (GLP - 1) analogue liraglutide in three early stages of type 1 diabetes.
GLP-1 agonists in type 1 diabetes. [2022]Despite years of research in the field of type 1 diabetes, patients with the disease remain without a therapeutic agent that can alter the underlying immune response in a clinically beneficial way. Glucagon-like peptide 1 agonist therapies have shown some promising effects in terms of positively affecting overall beta cell health and increasing beta cell mass, primarily in mouse models. The three agents of this class currently available for patients with type 2 diabetes have shown beneficial clinical effects on glucose control in this patient population. The purpose of this article is to review the preclinical and clinical data of these agents to date with a focus on the potential immunological and clinical benefits these drugs may have on patients with type 1 diabetes.
Effects of insulin degludec and insulin glargine U300 on glycaemic stability in individuals with type 1 diabetes: A multicentre, randomized controlled crossover study. [2021]To compare the effects of insulin degludec (IDeg) and insulin glargine U300 (IGlarU300) on glycaemic stability in subjects with type 1 diabetes.
Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with One Year of IDegAsp Therapy in Poorly Controlled and Non-compliant Patients [2022]To evaluate the efficacy of degludec/aspart (IDegAsp) insulin co-formulation in children and adolescents with poorly controlled type 1 diabetes (T1DM).