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.
Ten years of R&D, six of which led to a successful pioneering application with a human patient in 2012. A neurosurgical procedure using these stem cells was approved by the national medical research ethics committee in South Africa in 2015. A clinical trial using these cells will begin in September 2016.
About Our Team
Creator: Anthony Stonefield
Location: New York
Bio: Serial entrepreneur in innovations with 24 years of experience in venture development globally. Head of Healthcare Solutions for an asset management firm in Switzerland and the U.A.E. Biology degree from UC Santa Cruz. Pioneered mobile content business with the first international ringtone business that generating over $1.5 billion in sales. Has raised over $25 million in venture financing for disruptive technology ventures and has led innovation projects for three Fortune 500 companies.
Hospital Affiliation: Frere Hospital
Title: Co-founder & Executive Chairman
About Team Members
Chief Operating Officer, Bachelor's degree in Chemical Engineering
Biography: Seasoned executive in the pharmaceutical and specialty chemical industries having led several businesses in the US, UK and South Africa, including regional divisions of Ciba-Geigy/Novartis and Rohm & Haas. Successfully started up or turned around several companies. Degree in Chemical Engineering. Five years of local legal, commercial and regulatory review for international stem cell business projects.
Title: Chief Operating Officer
Advanced Degree(s): Bachelor's degree in Chemical Engineering
Chief Legal & Financial Officer, Certificate of Chartered Accounting
Biography: Peter is a Chartered Accountant, a Master Tax Practitioner and an admitted Advocate of the High Court of South Africa. He is the founder of specialized financial-legal consultancy, encompassing 20 years of experience in capital raising, deal corporate finance structuring, IP protection, and developing and implementing cross-border structures, especially in relation to international trade, finance and investment, including compliance, particularly with regard to OECD imperatives.
Title: Chief Legal & Financial Officer
Advanced Degree(s): Certificate of Chartered Accounting
About Our Company
AutoRegenic Cell Laboratories
Location: C/o Horizen Ventures, 161 West 54th Street
New York, NY 10019
YTD Sales: Working on it
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.
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;
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.
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.