Replies to post #34684 on CBA Florida Inc. (fka CBAI)

[MrLong]

StLXer, this same process occurs in the USA today by a compnay called Regenexx. They extract cells from the host multiply and reinsert back into the same host: autologous stem cell procedure. This is stem cell therapy. Regenexx has done this for hundreds of paitients without FDA approval.

The problem:
Anytime one manipulates, multiplies or expands an autologous cell the FDA defines the blood as a drug and it requires an IND or BLA license. To get an IND or BLA what must you have? Trials proving the safety and efficacy of the procedure. Overseas the so-called "snake oil" therapies have been performed with no data on the safety and efficacy from any proven clinical trials.

TCA Cellular isn't immuned to the process. They are just now beginning a clinical trial. TCA will need to complete Phase I - IV trials under the FDA guides. The procedure however will still benefit many just under the "Investigational" umbrella which is now covered albeit more approval is needed by the insurance or these are often sponsored by the investigating institution.

CBAI today is a manufacturer of pharmaceuticals. It is FDA accredited and has other accreditations. CBAI will need to submit its plans for BLA and IND licensure because the next pharmacy will have your original blood sample on record and it will expand it manipulate it and add to it in the future to treat your ailment genetically. Expansion and multiplication of your family-related blood will treat multiple people. The FDA has extablished that public banks will need the BLA licensure because that blood is being drawn from one body and inserted into a different body: allogeneic unrelated. How does a family-related bank need the BLA licensure? Today for adults it is not uncommon to mix (double) the stem cell therapy treatment: autologous and HLA matched donor allogeneic are mixed to double the dosage. This therapy treatment after next year requires licensure.

Costs:
The cost to multiply or expand is again manufacturing in a mass production setting the next form of a "pill". There's cost in having the setting to produce x units of a pill and there will be costs due to expand the blood; new pill.

Profits:
This is the new-aged Pharma. Billions to be made just like the pill has made billions. It is why CBAI is positioned for tremendous growth: Demand. The US insurance policies have dodged the bullet for years and it has left the privates on the sidelines waiting for this very moment. Include stem cell storage in the benefits package of every American as routine covered costs and where do you see CBAI revenues going?

I can't wait for this to heat up. Great commentary... Thanks
http://www.tcacellulartherapy.com/fda_clinical_trials.html

[MrLong]

Forgot to mention in September 2010 all insurance companies pay for storage to treat under a growing list of proven FDA UCB therapies. To force insurance companies to comply what does the new healthcare law require insurance groups to do? Pay for all genetic testing of pregant moms and newborns. If a problem is detected in the blood they must pay to cryostore it. What does that do for demand for U.S. storage?

There are 4.2 million births annually in the U.S. On average 150 birth defects alone each yr. Last year new U.S. Leukemia cases amounted to 1.5 million; all given the big green light to treat with UCBs as "routine care" and no longer "investigational" or "experimental". The same for sickle cell, thalassemia etc. That was the loophole insurance groups used to deny. If "experimental" or "investigational" it was a challenge to get them to pay.

The gov't has also commissioned a panel to look at Orphan drugs that can be spead up through the process to get regulatory approval. These were held up by the FDA. We are inches from the finishline of a marathon race.

So add in diabetes, parkinson's, cerebral palsy, and many other stem cell treatable diseases and disorders to the tune of millions in need of a treatment and I see major demand for storage and our capacity is +250 million.

"It's money time!"