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  • j
    Islet Allotransplantation Into Pre-vascularized Sernova Cell PouchTM – Preliminary Results from the University of Chicago

    P. J. Bachul1, P. E. Borek1, G. S. Generette1, A. Perez-Gutierrez1, K. Jayant1, K. Golab1, L. Basto1, L. Perea1, M. Tibudan1, C. Thomas2, L. Philipson2, J. Fung1, P. Witkowski1

    1Surgery, University of Chicago, Chicago, IL, 2Medicine, University of Chicago, Chicago, IL

    Meeting: 2021 American Transplant Congress

    Abstract number: 57

    Keywords: Bioengineering, Engraftment, Hyperglycemia, Islets

    Topic: Clinical Science » Pancreas » Pancreas and Islet: All Topics
    Session Information

    Session Name: Pancreas & Small Bowel

    Date: Saturday, June 5, 2021

    Session Time: 6:00pm-7:00pm

    Presentation Time: 6:30pm-6:35pm

    Location: Virtual

    *Purpose: Previous first-in-human pilot study showed safety but the conditions did not allow for detectable islet function post-transplantation into the pre-vascularized Sernova Cell Pouches (SCPs) implanted subcutaneously. Herein, in the current Phase I/II study we tested clinically, islet engraftment in modified conditions after transplantation into the SCP.

    *Methods: First, SCPs were implanted below the anterior rectus sheath in type 1 diabetes patients with severe hypoglycemia unawareness and no stimulated C-peptide. Three weeks later Thymoglobulin, tacrolimus, and mycophenolate were initiated. During the infusion, islets were suspended in the patient’s own serum instead of saline to provide an optimal microenviroment for engraftment. Islets with purity over 90% were transplanted. A sentinel pouch was excised for evaluation 3 months after each transplant. Islet graft function was monitored based on glucose control, C-peptide and insulin usage.

    *Results: Early in the ongoing study, wound infection required SCP excision in one of six SCP implanted individuals. The two furthest advanced patients received two subsequent islet transplants into the SCPs resulting in persistent islet graft function (positive serum C-peptide). Peak serum C-peptide remains currently at a level of 0.4-0.48 ng/ml, at 6 and 3 months after the second transplant in first and second patient, respectively. Islet engraftment was 9-fold higher when the islet mass was reduced by half to 3,300IEQ/kg (0.8 ml of tissue) during the second transplant in both patients. In the first patient, glucose control improved as A1c decreased from 6.3 to 6.0, insulin requirements dropped by 23% and CGM Time Below Range (TBR) dropped from 12% to 5%. In the second patient A1c dropped from 10.3 to 7.6, insulin requirements dropped by 40% and Time Above Range dropped from 76% to 48%. None of the patients experienced severe hypoglycemic episodes after the second islet transplant. Of note, both patients lost initially 7-15% of body weight and maintained stable weight afterwards. Preserved islet anatomy and endocrine function were found on histopathological evaluation of the vascularized environment within excised sentinel pouches.

    *Conclusions: Modified conditions resulted in persistent islet graft function after SCP transplantation. Limiting islet mass to 3,000IEQ/kg per transplant significantly improved islet engraftment into Sernova Cell Pouches.


    To cite this abstract in AMA style:
    Bachul PJ, Borek PE, Generette GS, Perez-Gutierrez A, Jayant K, Golab K, Basto L, Perea L, Tibudan M, Thomas C, Philipson L, Fung J, Witkowski P. Islet Allotransplantation Into Pre-vascularized Sernova Cell PouchTM – Preliminary Results from the University of Chicago [abstract]. Am J Transplant. 2021; 21 (suppl 3). Accessed June 5, 2021.

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  • N
    I really, really don't get it. Isn't good/great news supposed to make a company more valuable? confused.
  • S
    “I believe Sernova is the first company in the world to demonstrate a subcutaneous vascularized device with therapeutic cells able to produce insulin in the bloodstream across multiple patients with the most severe diabetes.”
  • D
    Only a matter of time .... and you’re regret will be not buying more! Company has cash in the bank and positive results awaiting .... to the moon
  • j
    looks like great progress on the direction of A1c in second patient... a drop from 10.3 to 7.6 that's incredible..
    even the first patient improved from 6.3 to 6.0 that's excellent in my opinion
  • R
    Very very looking forward to next week :)
  • B
    Is there a discord chat för Sernova corp shareholders?
  • j
    On verge of historical 21st century medical breakthrough
  • G
    a good day in the books
  • G
    I think, only the good study results are confirmed with corresponding numbers at this virtual even/presentation -->
    American Transplant Congress (ATC)
  • J
    As a Clinical Pharmacist, I believe this company has the potential to functionally cure type 1 and type 2 Diabetes. Looking at its market cap and cash on hand it looks hugely undervalued. With continued good results, it's a potential 100 bagger! Dr. Goossen PharmD, BCGP, RPh
  • M
    Sernova Global Partnership Family Office Presentation
    Sernova Global Partnership Family Office Presentation
  • M
    Is anyone concerned about the following claim in the abstract? "Early in the ongoing study, wound infection required SCP excision in one of six SCP implanted individuals."
  • A
    I can't understand why this SP isn't sky-high. So much potential.
  • D
    Big news coming soon.
  • j
    check out latest ... it starts in german but goes to english listen close to time stamp 38:30
  • A
    Exciting tech, no real competition. This would be a great tech to have.
  • W
    William Tell
    SVA will be 3.50 to 5.00 dollars by the end off June 2021.
  • j
    looks like more continuing good news....should help