Regenerative Medicine Treatment Value Equation

Regenerative medicine is a buzz phrase right now.  Patients, providers and politicians are all in favor of "Regenerative Medicine".  There are three major components to evaluate when assessing treatment value (TV).  Treatment value is directly related to overall efficacy (E) of the drug or procedure and inversely related to cost (C) and risk (R).  A simple equation can define it:

TV = E / C x R2

That is Treatment Value = Efficacy divided by Cost times Risk squared.

We need treatments of high value with maximal efficacy that have reasonable costs and minimal risks.  When evaluating new potential "Regenerative Medicine Treatments", consider this equation.

Please post any comments or suggestions.

AM
ApexPRP.com

Embryonic Stem Cells used to Treat Spinal Cord Injury Patient

For the first time in history, embryonic stem cells have been used to treat a patient with an acute spinal cord injury.  According to several reports the protocol calls for using the treatment within two weeks of the initial injury.  Geron, the company sponsoring the trial has spent years and tens of millions of dollars just to get to this first patient.  The hope is for this first phase that safety can be demonstrated.

We have officially entered the era of biologic medicine.  For quite some time there has been promise, now there is action.  It is hard to compute the amount of effort that has likely gone into getting to just this point.  It is the researchers and especially this first brave but tragic patient that deserve the credit for this advancement.

In the future, the use of either adult stem cells or induced pluripotent stem cells may become a better option.  For now, regardless of your stance on the ethics of embryonic stem cells this day must be marked as a milestone.

AM
Total Tendon

HalfDome.TV

Trial of Embryonic Stem Cells for Spinal Cord Injury

The FDA lifted a hold on Geron's trial of embryonic stem cells to treat spinal cord injuries.  Geron hopes to begin the trial by the end of the year.  The specific cell line in use for this trial is GRNOPC1 which contains cells called oligodendrocyte progenitor cells. 

This is an interesting development.  Geron's stock popped 17% ($80-90 million in market cap) today on the news.  That speaks to the importance of a regulatory pathway for novel biologic treatments.  With the value in their stock, they can fund at least part of the trial.

Any thoughts out there on how to best fund new biologic treatments through the early clinical stages?

AM

Stem Cell Types

There are three basic types of stem cells. Embryonic stem cells as the name implies come from embryos and have ethical issues surrounding them. Adult stem cells can be purified from a variety of sources including bone marrow and fat. Finally, induced pluripotent stem cells are artificially made from somatic cells such as skin cells. This final type of stem cells is produced by a form of genetic engineering. Viruses are used to insert genes and change the characteristics of the cells.

Embryonic and induced pluripotent stem cells are years away from any real value as treatments because they carry a serious risk of cancer. This has not been well outlined in the press but needs to be discussed. Adult stem cells are used for a variety of treatments already including bone marrow transplants and other indications.