About our project

The problem we solve: Accelerating the productization of a new personal (autologous) biological medicine (rebirthed pluripotent stem cells) that regrow neural stem cells in the spinal cord canal to reconnect separated spinal cords in victims of severe chronic spinal cord injury.

About our solution: This stem cell culturing and application process is already proven to work in in-vivo animal and in-vitro human tissue trials and in a compassionate care experimental operation with a human patient in 2012. The process is safe and ethical, and promises to be very affordable.

About Our Company

How We Help Patients

How We Help Physicians

How We Help Hospitals

How We Help Partners

Innovation Details

Intellectual Property Summary
The novel techniques, procedures and materials we employ in relation to Somatic Cell Nuclear Transfer, pluripotent stem cell differentiation, and implantation media and processes ("Techniques") encompass a set of proprietary processes that are held by the company as trade secrets.

Clinical Information
Technique was refined over 10 years in-vitro and -vivo in 2 stages: Stage 1 - refined iSCNT to produce cloned animals, demonstrating that embryos derived through this process produced live-birth animals without displaying deleterious effects of heteroplasmy. Animals have been successfully cloned by our team, including King Blue Wildebeest, dairy production cow and Merino sheep. Stage 2 - harvested the pluripotent stem cells from blastocysts, expanding and differentiate them into pre-neural cells for re-implantation into an excised gap in spinal cords. This process saw the return of full motor functions in a rabbit trial and, subsequently, in the first human quadriplegic patient trial who now, nearly 4 years later, has significant body sensation, some upper body and abdominal muscle mobility, and has been able to stand with assistance for up to 45 minutes; see http://www.facebook.com/MakingTommieWalk/

Regulatory Status
No application has been made to the FDA to date due to resource constraints. The point of raising financing to productize the Technique is to support, complete and expand upon a clinical trial that is currently spinning up—using the experimental product of our Technique in a research hospital South Africa—so that we may utilize the trial protocols (SOP, cGMP, material sourcing, peer review and third-party validations) plus the results of the clinical trial, to support of an application to the FDA and Canadian Dept. of National Health and Welfare to begin similar clinical trials in North America.

How we will use the funds raised
We aim to raise $45,000 to help rapidly formalize the clinical translation and outreach process which will encompass: Project management - $10,000 Med-tech and legal research - $15,000 Specialist biomedical & business consultancy - $10,000 Travel/telecom/admin/logistics - $2,500 Web & publicity collateral development - $5,000 Capital raising costs - $2,500 The project is planned to be completed in 90 days and will lead into the company raising commercial and research grant capital to formalize a path to clinical trials in North America and the establishment of the necessary corporate and legal structures and partnerships to begin operating.

Thank You
Nerve damage is very difficult to remedy. Severe C1-4 spinal cord injury, leading to comprehensive quadriplegia, is an expensive life-destroying affliction and is effectively incurable. Quadriplegic life, costing between $4M and $6M to sustain with dignity, can easily lead to destitution or suicide. Such crippling spinal injury is a medical setback and emotional torture that can destroy patients and their personal relationships. Our team is dedicated to expediting the advancement of a set of techniques, materials and processes—for producing re-originated patient-specific stem cells ethically, practically and cost effectively—that is showing encouraging safety and effectiveness for regenerating spinal cord tissue endogenously.

Supporters

• 
  Ephraim Zagelbaum, Master’s Degree in Business Administration from Seton Hall University
  10/06/2017 - Followed the project.
• 
  Ephraim Zagelbaum, Master’s Degree in Business Administration from Seton Hall University
  10/06/2017 - Liked the project.
• 
  Mr. Alex Fair, MS
  10/25/2016 - Interested in investing in the project.
• 
  Alex Fair, MS
  10/04/2016 - Backed the project for $1
• 
  Uzzwal Khanal, Forunder
  09/26/2016 - Followed the project.
• 
  Dr. Jonathan Landry, MD, MS, MBA
  08/25/2016 - Liked the project.
• 
  Casey Quinlan, PhD in autodidact
  08/24/2016 - Liked the project.
• 
  Alex Fair, MS
  08/16/2016 - Liked the project.
• 
  Zachariah George, M.S., B.Tech.
  08/10/2016 - Followed the project.
• 
  Zachariah George, M.S., B.Tech.
  08/10/2016 - Liked the project.
• 
  Victor Knutzen
  08/10/2016 - Followed the project.
• 
  Philip Kiracofe
  08/09/2016 - Liked the project.
• 
  Lawrence Graham
  08/08/2016 - Followed the project.
• 
  Lawrence Graham
  08/08/2016 - Liked the project.
• 
  Jeffrey Saad
  08/04/2016 - for the Innovation Supporter
• 
  Jeffrey Saad
  08/04/2016 - Liked the project.
• 
  Alex Fair, MS
  08/03/2016 - Interested in trying the project.
• 
  Michael Vollmer
  08/02/2016 - Liked the project.
• 
  Shane Dewing
  08/01/2016 - Liked the project.
• 
  Shane Dewing
  08/01/2016 - Followed the project.
• 
  Diane Stone
  07/29/2016 - Followed the project.
• 
  Diane Stone
  07/29/2016 - Liked the project.
• 
  Josie Eyre
  07/28/2016 - Liked the project.
• 
  Josie Eyre
  07/28/2016 - Followed the project.
• 
  Sean Walsh
  07/26/2016 - for the Dream Maker
• 
  Rick Myers
  07/26/2016 - for the Pioneer Supporter
• 
  Alex Fair, MS
  07/26/2016 - Followed the project.
• 
  Sean Walsh
  07/26/2016 - Liked the project.

Comments

• 
  Alex Fair posted on 3rd November, 2016

  Thanks for the update - great news! Keep us posted.

  Report as Spam

Updates

• Update #1

  17th September, 2016

  ARC implantation clinical trial commences!

  We have received the MRIs, Patient Informed Consent declarations, and skin biopsies from the first two patients in the clinical trial. We're approximately halfway done culturing the ARC cells for the first patient -- a 24 year-old man whose injury is just under one year old -- whose operation is scheduled fro October 26th.

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• Update #2

  3rd November, 2016

  Delayed start for first patient

  Due to the fact that Frere Hospital has not yet received the growth media required by our team, the first patient operation in the clinical trial has been postponed. The patient's ARC mass is ready. It is expected to take place within the next 10 days. The first patient is a incomplete quadriplegic which add an interesting dimension to the project as scar tissue needs to be extremely carefully excised to preserve those neural paths that are still functional.

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