Seems FDA now wants to control and make $$$$$$$$$$$$$$

barbara

Pioneer Founding member
Thanks jgp. The FDA, in my opinion, is more like a big business these days. They are indeed all about the $$$$$$$$$$$$$$.

Here's the story in case the link above goes cold.

Newly FDA-Approved Platform Will Rapidly “Manufacture” Stem Cells to Repair Our Bodies

Doctors at the Mayo Clinic have received FDA approval for a platform that can manufacture stem cells by the billions in just days, in contrast to previous methods of making stem cells that took months.

Up until now, any patient receiving stem cells for a medical treatment has had to wait months for their doctors to create enough cells to make multiple doses. But that could soon change: the FDA recently approved an automated bioreactor, developed by scientists at the Mayo Clinic’s Center for Regenerative Medicine, that can manufacture stem cells by the billions in a matter of days.

Stem cells have the unique capability to transform into any sort of specialized cell needed in the body, making them especially promising for medicine that replaces nonfunctional or dead cells. The Mayo Clinic’s new platform allows for the multiplication of stem cells harvested from bone marrow. Significantly, it can manufacture stem cells from a healthy donor as well as from a patient themselves, which could allow treatments even in cases when the patient’s own cells are not usable.

“The new platform represents a giant leap in regenerative medicine, in which stem cells currently are being investigated as treatments for wide-ranging medical conditions,” Guojun Bu, neurologist and associate director of the Mayo Clinic’s Center for Regenerative Medicine, said in a press release. https://newsnetwork.mayoclinic.org/discussion/fda-clears-way-for-mayo-clinic-to-accelerate-production-of-stem-cells-for-clinical-trials-through-automation/

THERAPY OF THE FUTURE
The new platform is among the U.S.’s first approved automated methods to manufacture stem cells, which may allow the Mayo Clinic to accelerate its existing studies using stem cells. A recent Mayo clinical study found stem cells could be reduce inflammation in patients who have received lung transplants. Another has explored the possibility of using stem cells to treat arthritis.

But in order to bring these treatments out of trials, they need to be tested rigorously; and for that, doctors need lots and lots of stem cells.

“Although Mayo Clinic has been poised to scale up regenerative clinical trials, to date we did not have the capacity to support them,” said Abba Zubair, Mayo Clinic’s medical director for transfusion medicine and the Human Cell Therapy Laboratory, in the press release. “With this new technology, we now can develop phase II trials enrolling larger numbers of patients to fully test the efficacy of cell-based therapies.”

Mayo Clinic doctors plan to use the stem cell platform to advance therapies in areas like Alzheimer’s, Parkinson’s, and even heart disease.

Indeed, stem cells have shown promise in a remarkable range of medical treatments. Scientists have used them to grow working muscle tissue, restore mobility to paralyzed animals, and even treat a leading cause of blindness. Additionally, as doctors have learned how to extract these shape-shifting cells from new sources, like tooth root pulp, it has averted much of the controversy that comes from extracting them from human embryos.

Add in such new methods for rapidly producing cells, and all of this points towards a promising future for medicine in which a patient’s own cells can be used to safely and effectively heal them from within.
 

barbara

Pioneer Founding member
"The whole brushing sampling and SOX9+ BCs cloning procedure was carried out on 15 individuals with a recovery rate of 100%."

This does give one hope. With that kind of success, what on earth is the world waiting for? There are so many suffering from lung disease. China has over 100 million. I hope scientists are paying attention to this important research and will be able to collaborate and move forward quickly in other countries.
 

jgp

Member
Mayo clinic fda approved

Barb; Mayo clinic can now multiply stem cells by the billions every day and it was just approved by FDA. Just think if we could connect Mayo with the SOX9+BCs scientists from China we might have a cure or great improvements soon. I wish I knew how to tell Mayo Clinic whats going on. God bless.
 

barbara

Pioneer Founding member
It's difficult to know if Mayo would know about this. I wish that scientists shared information better. That would help to speed up the process in my opinion. If you can find the name of the person who heads pulmonary research at Mayo, that would be a good start. I have often e-mailed researchers and gotten a response.
 

jgp

Member
Contacted Mayo Clinic

Barb; I faxed the head of Mayo research the Sox9+bcs report, no answer. Have you heard of Crispr and lung diseases? There is a flaw in our DNA that causes all lung problems, what Crispr does is pull out those defective DNA and correct them, now I don't know if once your sick it helps, but it can stop you, from ever getting sick. All you have to do is google Crispr and lung diseases. I'm going on 75 too late for me but this will be awesome for younger people. God bless.
 

barbara

Pioneer Founding member
Good for you that you sent it to Mayo. I hope that someone paid attention to it.

Here's a recent article on CRISPR. It states that this method could be used to treat diseases like Alzheimer's which includes more than one defective gene. It didn't say prevent the disease, it said treat it, so I'm assuming CRISPR will be a valuable treatment even for those who already have a disease. And it could be used together with other therapies which could restore tissue and organs.


CRISPR edits DNA outside of the cell for the first time
30th April 2018
BioTechniques
Abigail Sawyer

Scientists hope the breakthrough will rapidly advance personalized cancer treatments.

Scientists at Christiana Care Health System’s Gene Editing Institute (DE, USA) have made a breakthrough in the use of CRISPR for gene editing by editing DNA in a test tube. This marks the first time DNA has been edited by CRISPR outside of the cell.

The researchers hope this will enable them to quickly and precisely engineer multiple changes to a DNA code. It is believed that this new CRISPR technology, detailed in a paper published in The CRISPR Journal, could be utilized as a diagnostic tool, replicating genetic mutations found in tumors of cancer patients.

The rapid identification of the correct mutation in an individual’s tumor will allow a more targeted treatment strategy to be implemented as mutations that cause cancer can differ from one person to the next.

“With this new advance, we should be able to work with laboratory cultures and accomplish gene edits in less than a day, significantly reducing the time required for diagnostics compared to other CRISPR tools, and with much greater precision,” commented Eric Kmiec, the director of the Gene Editing Institute and lead author of the study.

“This is particularly important for diagnostics linked to cancer care where time is critical.”

Kmiec also explained that unlike other CRISPR tools that can only edit or repair shorter segments of DNA code within a gene, this new CRISPR tool could be utilized to remove and replace entire genes. This could enable CRISPR to treat diseases such as Alzheimer’s, which appear to involve damage in multiple genes. The new treatment would involve gene replacement instead of gene editing.

Genes modified by the team were contained in a DNA plasmid and utilized an enzyme referred to as Cas12a. The CRISPR-Cas9 system has been the root of much excitement over recent years and whilst it is famously effective at modifying genes inside a cell, it performed poorly when it was trailed by the research team in vitro.

“It could be that there is something within the very complex machinery of a cell that allows the Cas9 enzyme to more easily accomplish deletions and insertions,” explained lead author Brett Sansbury.

“But it performed very poorly in our cell-free extracts.”

Another benefit of Cas12a is that it produces DNA with sticky ends, unlike Cas9 that produces DNA with blunt ends. This allows for the easier insertion and attachment of a new code.

The team is now working to create a commercial product utilizing the technology for cancer diagnosis and believe that now they have brought the gene-editing process in vitro, they will be able to gain crucial insights regarding exactly how CRISPR works to modify genetic code.

Sources

Sansbury BM, Wagner AM, Nitzan E, Gabi T, Kmeic EB. CRISPR- directed In Vitro Gene Editing of Plasmid DNA Catalyzed by Cpf1 (Cas12a) Nuclease and a Mammalian Cell-Free Extract. The CRISPR Journal. 1:2 (2018); https://news.christianacare.org/2018/04/researchers-use-crispr-to-edit-dna-outside-of-the-cell-for-the-first-time/
 
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