Blood & The Search For A Universal Drug Delivery System

The doctrine that we are all equal under God applies in reality to the very Blood of humanity that runs through our veins. This was the shocking truth that changed an age old way of intellectual & class division. After millennia Science did that not faith. The fluid of life is an interchangeable commodity that drives the body and mind. A genetic brain unique to a person's cells is common enough to be of practical benefit. Donors of all types, colors and creeds can have some siphoned off and provided to those that need a refill. 

We accept the DNA of another to live on, with new Blood, without question and without any harm.

With 7.2 Billion humans on the planet you would think that we'd have enough of the Red stuff to go around. Think again. We don't even have enough fresh supplies to meet current demand, let alone future requirements based on the donation system. How can we expect this system to suddenly change to meet the forecasted demand when the population hits 10 Billion within a few decades and then 15 Billion a generation or two later?

Enter science, as usual, to solve the human evolutionary dilemma - Create it.

Not only is it possible to do so now, in inexhaustible volumes to satisfy all, but those cell products can and will be modified by the Scientists & Doctors of this 2nd Blood Revolution to deliver the needed solutions against the parasites, funguses, viruses, bacterias et al. that plague & kill daily in countless numbers.

Engineered weapons of the vascular system that naturally hone in and destroy invading pathogens.

The below provides a rough summary of how this is coming together from the perspective of ACTC and it's scientific colleagues.

Cheers

Phase 1 - Blastomere Derived Renewable Stem Cell Line
Phase 2a - Clinical Expansion & Banking of Hemangioblast Derived Megakaryocytes
Phase 2b - Engineered Variants for Drug Delivery Requirements
Phase 3a - Differentiation of Platelets, Red Blood Cells & Line Derivatives 
Phase 4a - Biocompatible Unit Preparation & Universal Distribution
Phase 4b - Locally Served Fresh Product via Bioreactor Automated Production

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REFERENCES:

Cell Research Jan 2011 - "Platelets generated from human embryonic stem cells are functional in vitro and in the microcirculation of living mice" - SCRMI, Univ of Illinois Chicago, Cha Univ, Harvard / BWH & ACTC 

Blood July 2014 - "Platelet bioreactor-on-a-chip" - Harvard / BWH, Univ Colorado & Colorado School of Mines, McGill, ACTC

Vector - Boston Children's Hospital Blog March 2014 - "The Platelet Whisperers" 

MedCity News April 2014 - "Biochip mimics how the body produces platelets so they could be made in a lab"

NY Times May 2014 - "Young Blood May Hold Key to Reversing Aging"

UCSF July 2014 - "Key to Aging Immune System Is Discovered" 

Proceedings of the National Academy of Sciences of the USA, June 2014 - Whitehead Institute & MIT - "Engineered red blood cells as carriers for systemic delivery of a wide array of functional probes"

The Scientist Sept 2014 - "Next Generation: Blood-Cleansing Device" - (Engineered MBL Protein use example in fighting Sepsis - with cell engineering it can be done without dialysis)

Advanced Cell Technology's Scientific Advisory Board

Dr. Langer's Lab & Dr. Jensen's Lab of MIT

The Scientist July 2013 - "Narrow Straits - Transfecting molecules into cells is as easy as one, two, squeeze." 

Proceedings of the National Academy of Sciences of the USA, Feb 2013 - "A vector-free microfluidic platform for intracellular delivery"

R&D, July 2013 - "Researchers put squeeze on cells to deliver"

Dr. Daley's Lab - "Hematopoiesis Research" - HHMI / Children's Hospital Boston / Havard  & "CellNet" - Children's Hospital Boston / Havard / Boston Univ & iPS mRNA Tech

Daley / Children's Hospital Boston / Harvard Patent Families: 

Biomechanical Induction of Hematopoiesis
Inhibition and Enhancement of Reprogramming by Chromatin Modifying Enzymes
Methods for Enhancing Hematopoietic Progenitor Cell Engraftment 
Method to Produce Induced Pluripotent Stem (iPS) Cells from Non-Embryonic Human Cells 
Method of Enhancing Proliferation and/or Hematopoietic Differentiation of Stem Cells
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Advanced Cell Technology's Patent Portfolio for the Blood Program:

INEXHAUSTIBLE SOURCE OF RENEWABLE STEM CELLS:

Blastomere Non-Destructive Human Embryonic Stem Cell Technology 

Blastomere Patent Family

5 Granted US Patents: 1, 2, 3, 4, 5

iPS/Reprogramming Renewable Stem Cell Derivation papers 1 & 2

iPS/Reprogramming Renewable Stem Cell Patent Family Portfolio: 1, 2 with examples A, B, C and SCNT Tech

EARLIEST YOUTHFUL BLOOD LINE POSSIBLE

HEMANGIO-COLONY FORMING CELLS - US Patent Granted & Patent Family 

HEMANGIO COLONY FORMING CELLS AND NON-ENGRAFTING HEMANGIO CELLS - App Pub March 2011 & Patent Family 

UNIQUE BLOOD LINE CELL PRODIGY DERIVATION:

(WO2011069127) LARGE SCALE GENERATION OF FUNCTIONAL MEGAKARYOCYTES AND PLATELETS FROM HUMAN EMBRYONIC 
STEM CELLS UNDER STROMAL-FREE CONDITIONS - PCT Pub June 2011 & US App Pub Dec 2012 & Patent Family  
(Note: SCRMI is a JV between ACTC & Cha Biotech of Korea - North American Rights belong to ACTC - Japan/Korea to Cha - ROW split)

(WO2014100779) METHODS FOR PRODUCTION OF PLATELETS FROM PLURIPOTENT STEM CELLS AND COMPOSITIONS THEREOF - PCT Pub June 2014 & US App Pub Sept 2014

Synthetic Biology & Process vrs Product - is this the Stem Cell sector's next big commercialization challenge?

It has been ruled on by the Supreme Court and Affirmed in Federal Appeals Court and at the USPTO that naturally occurring biological matter cannot be exclusively owned. This was today confirmed again in the matter of Roslin Institute's desire to Patent the "clones" of their SCNT cloning process. After years of examination rulings and a lengthy legal challenge, the Federal Appeals court upheld the decision of the USPTO that no Patents will be issued on the product of the process that created Dolly, as it produced a copy of a nature, and therefore "Dolly's genetic identity to her donor parent renders her unpatentable." Further, Judge Dyk stated that "There is nothing in the claims...that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies."

The issue at hand is pertinent and important to note in that cells themselves are natural biological products, aren't they? Therefore they themselves, if unaltered scientifically, wouldn't be Patentable themselves therefore. The Process yes but the cell itself, if identical to the naturally occurring original, wouldn't?

Processes in the stem cell field are seemingly never ending...

The "product-by-process" standards that have applied to determining patentability by limiting duplicate product patents will need to be revisited to narrow the "product" window to only unique synthetic constructs. This developing legal framework of patent scope now calls into question old technology product claims and may give rise to a freedom to operate latitude the Courts are indicating on natural biological ownership.... or am I missing something here?

Are cells which are innovatively derived also being pushed to be genetically altered as a synthetic variant of the original as a requirement to secure a firm path to market?

Is an RPE cell derived from different innovative methods, such as hESC, iPS, SCNT, hpESCs, subject to a novelty test against an existing natural RPE cell in order to secure product claims? Will there be a race to alter the cells to create genetically unique versions in relation to the natural standard and the competitive versions?

Cheers  

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Dolly the Sheep-type clones ineligible for patent: appeals court
BY BERNARD VAUGHAN - Thu May 8, 2014 6:45pm EDT

(Reuters) - The method for cloning animals such as the famed Dolly the Sheep can be patented, but the resulting animals themselves cannot, a U.S. federal appeals court has ruled.

"Dolly's genetic identity to her donor parent renders her unpatentable," Judge Timothy Dyk wrote Thursday for the U.S. Court of Appeals for the Federal Circuit in Washington, D.C.

Pilar Ossorio, a professor of law and bioethics at the University of Wisconsin Law School, called the decision a victory for people who thought cloning animals was morally wrong.

"This ruling is taking away an incentive for research organizations to pursue more research into cloning, at least on the margins," she said.

Scientists Ian Wilmut and Keith Campbell of the Roslin Institute of Edinburgh, Scotland, generated international headlines and intense ethical debates in 1996 when they created Dolly the Sheep, the first mammal to be cloned from an adult cell.

Dolly, named after country singer Dolly Parton, was euthanized six years later after she was diagnosed with a progressive lung disease.

The institute, which owns a patent to a method of cloning called somatic cell nuclear transfer, applied for a patent over the clones themselves but was rejected by a U.S. Patent and Trademark Office examiner in 2008.

In February 2013, the USPTO affirmed the examiner's decision, saying the clones did not possess "markedly different characteristics than any found in nature."

In affirming the USPTO, the Federal Circuit said that nature, natural phenomena and abstract ideas were not eligible for patent protection.

Salvatore Arrigo, a lawyer for Roslin, said he was disappointed with the ruling.

"There's no doubt in anyone's mind that Dolly is man-made," he said.

Roslin had argued that its clones were distinguishable from their donor mammals, in part because environmental factors could make their shape, size, color and behaviors different than their donors.

The Federal Circuit disagreed, noting that Roslin itself had said that such differences were produced "quite independently of any effort of the patentee."

"There is nothing in the claims...that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies," Dyk wrote.

The USPTO declined to comment.

The case is In re Roslin Institute (Edinburgh), U.S. Court of Appeals for the Federal Circuit, No. 1407.

http://www.reuters.com/article/2014/05/08/us-ip-dollysheep-idUSKBN0DO1ON20140508