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PKX-001 for Type 1 Diabetes

Q: What is the desired outcome of this scientific investigation?

<p>This medical trial hopes to assess post-<a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> morbidity over the course of a year. As secondary objectives, investigators will analyze insulin independence at 90 days post-treatment, islet viability compared to current standards, and beta-2 score relative to existing norms.</p>

Phase 1

Recruiting

Led By James Shapiro, MD, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have had type 1 diabetes mellitus (T1DM) for more than 5 years

All control participants will be included according to the immunosuppression / engraftment regimen used in this pilot, specifically the current standard of care islet transplant at the University of Alberta Hospital: Alemtuzumab/Basiliximab, Anakinra, Etanercept, Mycophenolate Mofetil and Tacrolimus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-transplant

Awards & highlights

Study Summary

This trial is testing a new drug, PKX-001, to see if it can help islet cells survive isolation and keep them healthy and functioning. This study will involve up to 10 participants from the islet transplant waiting list.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

While PKX-001 itself may not be given directly to participants as medication, potential side effects could relate to the transplantation process such as inflammation at the site of injection in the liver, immune reactions, or complications related to immunosuppressive therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had type 1 diabetes for over 5 years.

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I am following the specific immunosuppression regimen for islet transplant at the University of Alberta Hospital.

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I often don't notice when my blood sugar is too low, despite using insulin carefully.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse event morbidity

Serious adverse event morbidity

Secondary outcome measures

Beta-2 score

Engraftment index

Glucose stimulated insulin release

+5 more

Trial Design

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,128 Total Patients Enrolled

ProtoKinetix Inc.UNKNOWN

James Shapiro, MD, PhDPrincipal InvestigatorUniversity of Alberta

8 Previous Clinical Trials

281 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the desired outcome of this scientific investigation?

"This medical trial hopes to assess post-transplant morbidity over the course of a year. As secondary objectives, investigators will analyze insulin independence at 90 days post-treatment, islet viability compared to current standards, and beta-2 score relative to existing norms."

Answered by AI

What is the aggregate sample size of this experiment?

"Affirmative. The clinicaltrials.gov database reveals that this experiment is actively looking for participants, and was initially posted on February 17th 2017 prior to its most recent update on October 12th 2022. 6 volunteers must be recruited from one location in total."

Answered by AI

Are there any current opportunities to participate in this research endeavor?

"Affirmative. As recorded on clinicaltrials.gov, this medical research has been accepting patients since its initial posting on February 17th 2017 and was last modified in October 12th 2022. The trial is actively searching for 6 participants from 1 site."

Answered by AI

Are adults aged 20 and above able to participate in this research endeavor?

"The requirements to join this medical trial state that participants have to be aged between 18 and 68. There are 219 studies for those under the legal age of majority and 923 for seniors beyond the retirement threshold."

Answered by AI

Is Antiaging Glycopeptide an innocuous treatment option for patients?

"Unfortunately, there is limited evidence of antiaging glycopeptide's safety and efficacy. Thus, it received a score of 1 on our team at Power's scale."

Answered by AI

What are the eligibility criteria for participating in this experiment?

"This clinical trial is recruiting 6 participants, aged between 18 and 68 years old, with type 1 diabetes mellitus. Additionally, all control subjects must adhere to the current standard of care transplant protocol at University of Alberta Hospital which involves Alemtuzumab/Basiliximab treatment alongside Anakinra, Etanercept, Mycophenolate Mofetil and Tacrolimus immunosuppression / engraftment regimens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Islet Transplantation Using PKX-001

2017. "Islet Transplantation Using PKX-001". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03073577.