After Japan, the US is advancing in adjusting its Stem Cell Regulation

Members of the US Congress are taking leadership on this issue.

Cell therapy, which involves the use of cells to restore healthy function in the human body, represents one of the most promising areas for the next generation of ground-breaking treatments in the 21st Century. Cell therapies have been shown to halt the progression of degenerative joint disease in the knee or hip and restore function to even a failing heart or damaged cornea. 

Scientific advances in the field include applications in cardiology, neurology, oncology, ophthalmology, and orthopaedics and there have been also promising studies for those with Alzheimer’s disease, Parkinson’s disease, diabetes, and cancer. Cell therapies are different from drugs in that they attempt to address the root cause of disease, rather than simply treating the symptoms of disease.

A human body consists of more than 100 trillion cells, communicating with its neural network by analysing and initiating needed activities at its cellular level. Every minute we are regenerating about 1,7 million cells, and like planet earth, raw material, i.e. cells produced in the bone marrow are not unlimited available as we all experience with aging.

Malfunction of a body, treated traditionally on the level of symptoms, can be treated at their roots with regenerative personalized stem cell treatment having a chance to support the body´s own defence system to repair damaged areas. Own stem cell treatment has shown in thousands of patient funded investigational studies that the treatment is safe and has the potential to improve the quality of life of patients considerably.

Despite the scientifically proven benefits of these treatments, cell therapies are generally not accessible to patients in countries following the outdated general drug related regulation for autologous cell therapies, an approach which is valid for therapies with highly manipulated chemical and biological based drugs, where side effects has to be carefully reviewed.

As a result, it takes on average more than $1 billion and ten to fifteen years of investment in development and clinical trials before drugs including autologous cell therapies can be brought to patients, besides those patented products are extremely expensive stretching the national health budgets beyond its already limited capacity.

For instance, Prochymal (its old name under Osiris) that is now rebranded as TEMCELL from Mesoblast/JCR likely will cost about $ 200K for a full treatment for GVHD. Provenge, the cellular prostate cancer drug from Dendreon is coming with a price tag of $ 93K. The most expensive drug in history, the gene therapy med Glybera will cost around $ 1.5 million per patient, and the first-ever human study of a treatment that uses reprogrammed adult stem cells in Japan according to Japanese source are believed to be in the range of $ 500 K per treatment.

It is most likely that FDA approved stem cell therapy in the average will cost somewhere between $ 100 K to $ 200 K per patient. The yearly cost of advanced cancer treatment is in the range of $ 100 K per year, and modern oral biological treatment of multiple sclerosis is $ 92 K beside the additional cost due to unemployment and additional medical care services.

The alternative, a medical procedure with own stem cells, has not only the advantage to be safe, as we are giving to the body what is from the same body, and therefore will not face immunoreactions, but will support the natural capability of the body to regenerate at its cellular level at $ 10K to $ 25K per treatment.

Autologous stem cell treatments appears to be more cost effective as it is personalized, is readily available and has a proven safety record. The question why there are so few clinical trials is relatively simple to answer. Drug development and clinical trials are usually sponsored by the Industry and by government agencies. Products which will developed via this clinical trial route will be patented by the developing and marketing company before it is marketed to recover the investment costs.

Autologous stem cell treatment is personalized, there will be no patent on the medical procedure and therefore neither the industry not government agencies sponsor those clinical trials. The only alternative to advance this field are patient funded investigational studies which will prove the feasibility of the medical concept. Blinded studies are not part of the patient funded investigational studies, in the frame of practice of medicine, as the patient expect at least a small benefit from the treatment.

Here are three videos from TIME WARNER TV NAINAMD reviewing various autologous stem cell treatment possibilities and its cryopreservation available today:

  1. TIME WARNER TV NAINAMD hosts Dr. Georg Graf on stem cells

  2.  TIME WARNER TV NAINAMD hosts Dr. Mark Berman  on Stem Cells

 

  3. TIME WARNER TV NAINAMD hosts Dr. Elliot Lander on Stem Cells

Japan has realized that the present drug regulation for stem cell treatment is outdated and have adjusted its regulation already avoiding the long and costly development via clinical trials as regulated for chemical and biological drugs. Other countries like the US or EU are still reviewing its regulation in general, although physicians have advanced in the frame of a medical treatment with minimally manipulated autologous stem cells with interesting positive results and no side effects!

Recent developments, recognizing the benefits of autologous cell therapies, numerous organizations and experts in the US, including the Regenerative Medicine Foundation, the Alliance for the Advancement of Cellular Therapies, and experts and leaders involved in the Bipartisan Policy Center, have called for a new framework to accelerate the availability of safe and effective cell therapies to Americans in need and improve U.S. competitiveness in the global marketplace.

Several members of the US Congress are taking leadership on this issue. Senator Mark Kirk (R-IL) and Senator Susan Collins (R-ME) have drafted legislation that would help advance safe and effective regenerative cell therapies through the FDA approval process and to the market so that patients can benefit from them.

Briefly the draft refers to: 
Adult stem cell both 361 low dose and 351 high dose, including Cord Blood UCB and suggest the acceptance of:

  • Interstate commerce and cell banking

  • Non-homologous use

  • Five year conditional approval for both 361 low dose and 351 high dose, after Phase 1 safety review passed and skipping Phase 3.

    Sponsor shall apply and pay for a BLA (Biological License Application) after the 5th year of marketing, which is $750K if approved.

The medical society and stem cell advocates are welcoming this development, which may help to improve quality of life of patients considerably where standard medical treatments has shown no further improvements of patients.

As after Japan, now also the US is trying to change its outdated stem cell regulation, and we hope that EMA in the European Union will open up further its advancement in treating patients with stem cells.

If you are interested in a patient funded autologous stem cell treatment please contact us to review whether you could become a potential patient for this kind of treatment. Further details please see at Cell Surgical Network or Cell Surgical Therapy.

Disclaimer:
Please note, for regulatory reasons there is a disclaimer on all our Social Media Pages of Aristoloft and CellTheraPhy Aristoloft including but not limited to our Facebook´s and Web-sites, showing that all data is for educational purpose only and that these statements have not been evaluated by the FDA (Food and Drug Administration) or similar health organisations. Any of the products / services are not intended to diagnose, treat, cure, or prevent any disease and as with any personal and anecdotal testimony, application results may vary.

 
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