Stem Cell Clinic

Stem Cell Doctors – regenocyte.com

By Stem Cell Doctors

Mary Holler, age 82, of Marco Island Florida is smiling again. Mary was suffering from dementia.

She and her husband sought Stem Cell Dementia Treatment.

She felt uneasy with her ability to function on a daily basis. Now, after undergoing a successful stem cell dementia treatment earlier this month, Mary is her old self again. She doesnt ask her husband, Peter, the same question 3-4 times in an hour anymore. Peter Holler, age 83, had become very concerned that his wife of 60 years was slowly losing her memory. She had been on medications for memory loss for several years but the deterioration in her recall accelerated in the last six months.It was starting to wear on him. He was losing his wife right in front of his eyes. Marys poor performance on an in-depth memory test revealed that that she was so advanced that should be in an assisted living facility. This frightened both the Hollers and their children.

Peter Holler sought out stem cell dementia treatment. He felt it was his wifes only option. Peter, no stranger to stem cells, had undergone a stem cell treatment by Dr. Zannos Grekos for his failing heart in 2008. He had experienced great success. Even my lung function improved dramatically, he recalls. Going back to the same group that he had trusted, he made arrangements to get the love of his life treated.

A track record of several successfully treated patients with dementia already existed. So the doctors knew exactly what to do. Heading the team is Dr. Hector Rosario, an interventional cardiologist and head of the stem cell program in the Dominican Republic. Dr Roberto Fernandez DeCastro head of the catheterization lab assisted in the procedure. Dr Grekos, Chief Scientific Officer for the company was present as well. Its very exciting to be able to have such a positive impact on a disease process that otherwise has such a grim prognosis, Grekos explained. The Dementia Treatmentprotocol used to treat Mrs. Holler had been developed specifically for patients with dementia by Dr Zannos Grekos.

Below arebefore(top) and after (bottom) angiogramsof Mrs. Hollers left internal carotid injections:

Stem cells collected from Marys bone marrow are subjected to an activation and concentration process. The stem cells were then injected into her cerebral circulation. Look at the difference, Dr Rosario exclaimed while pointing to the before and after pictures of the brain circulation. The increase in blood vessel flow was astonishing.Since only adult stem cells from the patient are used, the political, ethical, and medical issues are avoided and there is no risk of rejection.

Were able to normalize a patients neuro-cognitive (brain function) testing in 6 months after the stem cell dementia treatment said Zannos Grekos MD, commenting on the success of patients having received adult stem cell dementia treatment to reverse the effects of dementia. Peter Holler agrees, Not only does she not repeat questions any more, but she is also remembering things that she had forgotten. Its a godsend.

Dementia is a loss of brain function that occurs with age and certain diseases. Most types of dementia are nonreversible (degenerative).It affects memory, thinking, language, judgment, and behavior. Alzheimers disease is a common type of dementia.Dementia also can be due to many small strokes or poor circulation. This is called vascular dementia. Many dementias have a vascular component; these are referred to as mixed dementias. Stem cells are especially effective in treating these types of dementias.

Dr. Zannos Grekos colleagues in the world medical field are currently employing adult stem cell therapy and coordinating its application for patients who have exhausted all other traditional therapy options. His presentation at the 16th Annual World Congress on Anti-Aging Medicine & Regenerative Biomedical Technologies conference supports efforts by a global community of doctors that are striving to incorporate adult stem cell therapy into mainstream medicine.

Regenocyteis an international corporation located in Bonita Springs, Florida. Dedicated to leading the world in providing Adult Stem Cell therapies, Regenocyteutilizes the most effective and safest technologies and medical procedures in order to improve the lives of its patients. A video of Dr. Zannos Grekos presentation at the 16th Annual World Congress on Anti-Aging Medicine & Regenerative Biomedical Technologies is available for viewing on the companys website. Additional information on adult stem cell therapy as well as patient video experiences can be found at http://www.regenocyte.comor call (866) 216-5710.

To learn more about dementia please click here

For more information on Doctor Grekos, MD please click here

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Stem Cell Doctors - regenocyte.com

Top Regenerative Medicine Doctors | Stem Cell Centers

By Stem Cell Doctors

We are actively involved in IRB (Institutional Review Board also known as the Independent Ethics Committee) reviewed research for many different conditions in the regenerative medicine field. By doing so, we have developed (and continue to develop) many protocols and standards for others in our specialty field to utilize. As a leading practice in regenerative medicine, a unique feature within our clinics is that we don't rely on just one type of stem cell. Each of our clinics offers amniotic andconcentrated cord blood and bone marrowstem cells.

We have multiplelocations across the country with many more coming soon. Youll be glad to know that we retain protocol consistency within all our clinics. That means that along with a successful treatment, youll find care, respect, and understanding regardless of which clinic you visit. So if you refer a friend or loved one to one of our Stem Cell Centers, theyll be sure to receive the same great care as you did.

Are you a candidate? Click Here to learn more.

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Top Regenerative Medicine Doctors | Stem Cell Centers

Rheumatoid Arthritis Stem Cell Treatment | StemGenex

By Stem Cell Treatment

Stem Cell Therapy for Rheumatoid Arthritis

Today, new treatments and advances in Rheumatoid Arthritis research are giving new hope to people affected by Rheumatoid Arthritis. StemGenexStem Cell Research Centreprovides stem cell therapy for Rheumatoid Arthritis to help those with unmet clinical needs achieve optimum health and better quality of life. A clinical study registered through the National Institutes of Health (NIH) atwww.clinicaltrials.gov/stemgenex has been established to evaluate the quality of life changes in individuals with Rheumatoid Arthritis following stem cell therapy.

Stem cell therapy for Rheumatoid Arthritis is being studied for efficacy in improving the complications in patients through the use of their own stem cells. These Rheumatoid Arthritis therapies may help patients who dont respond to typical drug treatment, want to reduce their reliance on medication, or are looking to try stem cell therapy before starting drug treatment.

To learn more about becoming a patient and receiving stem cell therapy through StemGenex Stem Cell Research Centre, please contact one of our Patient Advocates at (800) 609-7795.Below are some frequently asked questions about stem cell treatment for Rheumatoid Arthritis.

Rheumatoid Arthritis is an autoimmune disease that attacks the bodys own tissues, specifically the synovium, a thin membrane that lines the joints. As a result of the attack, fluid builds up in the joints, causing pain in the joints and inflammation thats systemic.

Rheumatoid Arthritis (RA) is a chronic disease that can lead to long-term joint damage, resulting in chronic pain and loss of function and disability. Individuals suffering with Rheumatoid Arthritis can experience intermittent bouts of intense disease activity, called flares. In some individuals, the disease is continuously active and progressively becomes worse over time while others enjoy long periods of remission with no disease activity or symptoms. Early diagnosis and aggressive stem cell treatment for Rheumatoid Arthritis can potentially help improve patients' quality of life.

Stem cells that come from your adipose (fat) tissue have distinct functional properties including immunomodulatory and anti-inflammatory functional properties which have the capability of repairing and regenerating damaged tissue associated with disease and injury.

Upholding the highest levels of ethical conduct, safety and efficacy is our primary focus. Five clinical stem cell studies for Parkinson's Disease, Multiple Sclerosis, Osteoarthritis, Rheumatoid Arthritis and Chronic Obstructive Pulmonary Disease (COPD) are registered through the National Institutes of Health (NIH) at http://www.clinicaltrials.gov/stemgenex. Each clinical study is reviewed and approved by an independent Institutional Review Board (IRB) to ensure proper oversight and protocols are being followed.

Stem cells are the basic building blocks of human tissue and have the ability to repair, rebuild, and rejuvenate tissues in the body. When a disease or injury strikes, stem cells respond to specific signals and set about to facilitate the healing process by differentiating into specialized cells required for the bodys repair.

There are four known types of stem cells which include:

StemGenex provides autologous adult stem cells (from fat tissue) where the stem cells come from the person receiving treatment.

StemGenex provides autologous adult adipose-derived stem cells (from fat tissue) where the stem cells come from the person receiving treatment.

We tap into our bodys stem cell reserve daily to repair and replace damaged or diseased tissue. When the bodys reserve is limited and as it becomes depleted, the regenerative power of our body decreases and we succumb to disease and injury.

Three sources of stem cells from a patients body are used clinically which include adipose tissue (fat), bone marrow and peripheral blood.

Performed by Board Certified Physicians, dormant stem cells are extracted from the patients adipose tissue (fat) through a minimally invasive mini-liposuction procedure with little to no downtime.

During the liposuction procedure, a small area (typically the abdomen) is numbed with an anesthetic and patients receive mild to moderate sedation. Next, the extracted dormant stem cells are isolated from the fat and activated, and then comfortably infused back into the patient intravenously (IV) and via other directly targeted methods of administration. The out-patient procedure takes approximately four to five hours.

StemGenex provides multiple administration methods for Rheumatoid Arthritis patients to best target the disease related conditions and symptoms which include:

Since each condition and patient are unique, there is no guarantee of what results will be achieved or how quickly they may be observed. According to patient feedback, many patients report results in one to three months, however, it may take as long as six to nine months. Individuals interested in stem cell therapy are urged to consult with their physician before choosing investigational autologous adipose-derived stem cell therapy as a treatment option.

In order to determine if you are a good candidate for adult stem cell treatment, you will need to complete a medical history form which will be provided by your StemGenex Patient Advocate. Once you complete and submit your medical history form, our medical team will review your records and determine if you are a qualified candidate for adult stem cell therapy.

StemGenex team members are here to help assist and guide you through the patient process.

Patients travel to StemGenex located in Del Mar, California located in San Diego County for stem cell treatment from all over the United States, Canada and around the globe. Treatment will consist of one visit lasting a total of three days. The therapy is minimally invasive and there is little to no down time. Majority of patients fly home the day after treatment.

We provide stem cell therapy for a wide variety of diseases and conditions for which traditional treatment offers less than optimal options. Some conditions include Multiple Sclerosis, Parkinson's Disease, Rheumatoid Arthritis, Osteoarthritis and Chronic Obstructive Pulmonary Disease (COPD).

The side effects of the mini-liposuction procedure are minimal and may include but are not limited to: minor swelling, bruising and redness at the procedure site, minor fever, headache, or nausea. However, these side effects typically last no longer than 24 hours and are experienced mostly by people with sensitivity to mild anesthesia. No long-term negative side effects or risks have been reported.

The side effects of adipose-derived stem cell therapy are minimal and may include but are not limited to: infection, minor bleeding at the treatment sites and localized pain. However, these side effects typically last no longer than 24 hours. No long-term negative side effects or risks have been reported.

StemGenex provides adult stem cell treatment with mesenchymal stem cells which come from the person receiving treatment. Embryonic stem cells are typically associated with ethical and political controversies.

The FDA is currently in the process of defining a regulatory path for cellular therapies. A Scientific Workshop and Public Hearing Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products was held in September 2016 at the National Institutes of Health (NIH) in Bethesda, MD. Currently, stem cell treatment is not FDA approved.

In March 2016, bipartisan legislation, the REGROW Act was introduced to the Senate and House of Representatives to develop and advance stem cell therapies.

Stem cell treatment is not covered by health insurance at this time. The cost for standard preoperative labs are included. Additional specific labs may be requested at the patients expense.

Joint inflammation is a hallmark of rheumatoid arthritis. That includes: Stiffness, Swelling, Pain, Redness and Warmth, Fatigue, Malaise, Loss of Appetite and Muscle Aches.

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Rheumatoid Arthritis Stem Cell Treatment | StemGenex

Stem Cell Therapy for Knees vs Surgery – Which Works Best?

By Stem Cell Treatment

Risks and Benefits of Stem Cell Therapy for Knees

We are already aware of the several risks associated with knee replacement surgery. Theyre big and scary. When you choose stem cell therapy as an alternative for knee replacement, however, most of those risks evaporate. The biggest risk youll face is the risk of infection, but that is extremely rare because the procedure is so minimally invasive.

The benefits of stem cell treatment for knees, on the other hand, are huge. Check it out:

The procedure is relatively quick, especially compared to surgery. We have our equipment and labs in-house, and the outpatient procedure can be done in a single day (a few hours, to be more precise).

The costs involved are reasonable. Your initial consultation, exam, and treatment planning are all done for at a low cost to help reduce your treatment expenses.

Stem cell therapy for knees is natural. We do not produce synthetic stem cells. We dont even use donor cells from embryos or other adults. Instead, we use your own stem cells. We literally take your stem cells from one part of your body and inject them into your knees or other problem areas. And the entire treatment is done in one sitting. It is as natural as you can get!

Recovery time is minimal. With surgery, the recovery time can last for months, many of which you spend immobile or with your mobility severely limited. With stem cell knee injections, this is not the case. You walk in and walk out of the procedure on your own, and your daily routine should stay the same. In a few weeks, you begin to increase your activity levels and do more!

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Stem Cell Therapy for Knees vs Surgery - Which Works Best?

Crohn’s disease patients test experimental stem cell …

By Stem Cell Treatment

It's a painful, chronic, and for some, untreatable condition. More than 700,000 Americans suffer from Crohn's disease, an inflammatory bowel disease that causes inflammation of the digestive tract that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition.

Now, scientists in the UK have launched a new clinical study to test the use of a stem cell treatment for the inflammatory bowel disease.

Moeed Majeed has struggled to control his Crohn's disease for the past eight years.

"I remember suddenly getting a lot of pain in my abdominal area, having to go to the bathroom a lot more, which was very unusual, and I wasn't eating a lot because it made me feel sick," he told CBS News.

The chronic pain and fatigue became so debilitating he had to drop out of college and move home.

A new clinical trial at Queen Mary University of London is working to help people like Majeed whose symptoms aren't responsive to available drugs and surgery.

"What we're doing is using a patient's own stem cells to reset their immune system," said lead trial investigator Professor James Linsday.

Study participants with Crohn's receive chemotherapy to wipe out their faulty immune system. Doctors then use a stem cell transplant and hormone treatments to grow a new one.

Linsday says it's an intense treatment to combat what he calls a devastating disease.

"Anything that we can do that takes away the duration of that suffering is an excellent thing," he said.

The UK trial is a joint partnership with Bart's Health NHS. The same type of stem cell treatment has already been successful in treating multiple sclerosis and arthritis.

Majeed is documenting his health journey online. He's spent more than two months in the hospital and years trying to find a treatment that works.

"The trials are great. I think it's an awesome thing, especially with people looking to maybe find a cure," he said.

The stem cell trial will last about four years. British scientists say they see real potential for this approach to improve the lives of Crohn's patients.

2018 CBS Interactive Inc. All Rights Reserved.

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@ Stem Cell Treatment For Diabetes Diabetes Care Ada …

By Stem Cell Treatment

Medicine For Diabetics To Lose Weight The 3 Step Trick that Reverses Diabetes Permanently in As Little as 11 Days.[ STEM CELL TREATMENT FOR DIABETES ] The REAL cause of Diabetes ( Recommended ),Stem Cell Treatment For Diabetes Nowadays doctors have also started suggesting this drug to Type II diabetic people.Actos just meant for Type II diabetic people and should not be any consumed by those suffering from Type I diabetes. There are millions of people are consuming this drug and some of them are contented with the benefit. Diabetes is the long term disease that will be controlled but cannot be cured beautifully. So to fight the problem Actos is an ideal generic drug available. This drug can are a stretch of time and ideal storing place and condition is need. Thus Actos can be to become the dependable drug for all Type II diabetic guys. Stem Cell Treatment For Diabetes Paula Deen debuted a slimmer and healthier physique on duvet cover of People magazine this week. After revealing her type-2 diabetes diagnosis six months ago the southern chef has lost weight to the tune of 30 euros. Deen talks about weight-loss and the recent backlash. Stem Cell Treatment For Diabetes You should also test normal. This can be done by monitoring unique personal blood glucose level. In case the son or daughter is suffering from the disease you should make this an important step for done each and every. Maintaining a normal blood sugar level is important in controlling the upshot of the malady.,Stem Cell Treatment For Diabetes Living sugar free do not have to be boring initially it normally takes a lot more creativity in which to stay satisfied but the longer youre going without feeding your sugar addiction the simpler it will be stay strong. The best part is a person can can begin immediately and be on the in virtually no time at each of the. Stem Cell Treatment For Diabetes GlaxoSmithKline spent thousands of dollars for PR strategies to downplay and misrepresent coronary heart damage their drug was causing. Out and out lies and misrepresentation at the expense of thousands of diabetic patients who trusted their doctors advice to take the drug. Stem Cell Treatment For Diabetes There is often a saying - You are what you consume. That is very relevant together with a diabetic. You cant expect consume a sugar laden cake or a chocolate bar or candies and not have an take up your blood glucose levels., See what your medical symptoms could mean, and learn about possible conditions.

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The Stem Cell Treatment Process – regenocyte.com

By Stem Cell Treatment

Once you have decided this is the best option for you, we will determine if any other testing is needed which can be done at our facilities in Florida or wherever you live. We will then plan a date for your stem cell procedure in the Dominican Republic. The process begins with the extraction of bone marrow from the top of you pelvis and also from adipose tissue (fat) at the hospital. In our lab, the stem cells will be activated and multiplied by using naturally occurring growth factors. In this process of activation, the stem cells are customized for the purpose for which they will be used in treatment. For example, they can be activated to build muscle tissue for the heart, to rebuild blood vessels in the extremities or lungs or into neural cells for the central nervous system. This process is done overnight.

The following day the activated cells are returned to the patients body by a process which delivers the stem cells to the part of the body that is being treated. You will be informed of your actual reinsertion method as part of the course of treatment developed specifically for you and your injury or disease.

Once your procedure is completed you will spend anywhere from a few hours, to two days in the hospital depending on your specific treatment and your baseline condition. A full report regarding your procedure will be prepared by the treating physicians and will be sent home with you. You will be given follow up instructions and a schedule of follow-up tests to evaluate your progress. Periodically, you will be contacted by our patient care team with interpretation of your test results and to answer any questions you may have.

Our stem cell clinic will help coordinate all of your travel and transportation arrangements. You arrive at the Santo Domingo International Airport in the Dominican Republic and your transportation coordinator will be waiting for you just outside of the airport. They will have a placard with your name on it. Our team will coordinate with you while you are in the Dominican Republic, including transportation to and from the airport, the hotel, and the hospital.

Be advised that a valid passport is required for entry into the Dominican Republic. Information regarding obtaining a United States passport can be found at: The United States Department of State

We have successfully treated patients from all over the world. We pride ourselves in providing the best, most advanced treatment worldwide and look forward to talking with you, your family or friends regarding the possibility of having Regenocyte Stem Cell Therapy change your life.

To get started with evaluation or more information. Contact our stem cell clinic here or call us at (866) 216-5710

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The Stem Cell Treatment Process - regenocyte.com

Stem Cell Quick Reference – Learn.Genetics

By Somatic Stem Cells

Are you confused about all the different types of stem cells? Read on to learn where different types of stem cells come from, what their potential is for use in therapy, and why some types of stem cells are shrouded in controversy.

Researchers are working on new ways to use stem cells to cure diseases and heal injuries. Learn more about unlocking stem cell potential.

Somatic stem cells (also called adult stem cells) exist naturally in the body. They are important for growth, healing, and replacing cells that are lost through daily wear and tear.

Stem cells from the blood and bone marrow are routinely used as a treatment for blood-related diseases. However, under natural circumstances somatic stem cells can become only a subset of related cell types. Bone marrow stem cells, for example, differentiate primarily into blood cells. This partial differentiation can be an advantage when you want to produce blood cells; but it is a disadvantage if you're interested in producing an unrelated cell type.

Most types of somatic stem cells are present in low abundance and are difficult to isolate and grow in culture. Isolation of some types could cause considerable tissue or organ damage, as in the heart or brain. Somatic stem cells can be transplanted from donor to patient, but without drugs that suppress the immune system, a patient's immune system will recognize transplanted cells as foreign and attack them.

Therapy involving somatic stem cells is not controversial; however, it is subject to the same ethical considerations that apply to all medical procedures.

Embryonic stem (ES) cells are formed as a normal part of embryonic development. They can be isolated from an early embryo and grown in a dish.

ES cells have the potential to become any type of cell in the body, making them a promising source of cells for treating many diseases.

Without drugs that suppress the immune system, a patient's immune system will recognize transplanted cells as foreign and attack them.

When scientists isolate human embryonic stem (hES) cells in the lab, they destroy an embryo. The ethical and legal implications of this have made some reluctant to support research involving hES cells. In recent years, some researchers have focused their efforts on creating stem cells that don't require the destruction of embryos.

Learn more about the controversy behind embryonic stem cells and why new stem-cell technologies may bring it to an end. The Stem Cell Debate: Is It Over?

Induced pluripotent stem (iPS) cells are created artificially in the lab by "reprogramming" a patient's own cells. iPS cells can be made from readily available cells including fat, skin, and fibroblasts (cells that produce connective tissue).

Mouse iPS cells can become any cell in the body (or even a whole mouse). Although more analysis is needed, the same appears to be true for human iPS cells, making them a promising source of cells for treating many diseases. Importantly, since iPS cells can be made from a patient's own cells, there is no danger that their immune system will reject them.

iPS cells are much less expensive to create than ES cells generated through therapeutic cloning (another type of patient-specific stem cell; see below). However, because the "reprogramming" process introduces genetic modifications, the safety of using iPS cells in patients is uncertain.

Therapy involving iPS cells is subject to the same ethical considerations that apply to all medical procedures.

Therapeutic cloning is a method for creating patient-specific embryonic stem (ES) cells.

Therapeutic cloning can, in theory, generate ES cells with the potential to become any type of cell in the body. In addition, since these cells are made from a patient's own DNA, there is no danger of rejection by the immune system.

In 2013, for the first time, a group of researchers used therapeutic cloning to make ES cells. The donor nucleus came from a child with a rare genetic disorder. However, the cloning process remains time consuming, inefficient, and expensive.

Therapeutic cloning brings up considerable ethical considerations. It involves creating a clone of a human being and destroying the cloned embryo, and it requires a human egg donor.

APA format:

Genetic Science Learning Center. (2014, July 10) Stem Cell Quick Reference. Retrieved September 07, 2018, from https://learn.genetics.utah.edu/content/stemcells/quickref/

CSE format:

Stem Cell Quick Reference [Internet]. Salt Lake City (UT): Genetic Science Learning Center; 2014 [cited 2018 Sep 7] Available from https://learn.genetics.utah.edu/content/stemcells/quickref/

Chicago format:

Genetic Science Learning Center. "Stem Cell Quick Reference." Learn.Genetics. July 10, 2014. Accessed September 7, 2018. https://learn.genetics.utah.edu/content/stemcells/quickref/.

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Stem Cell Quick Reference - Learn.Genetics

Cell Therapy CMC and Analytics – The Bioprocessing Summit

By Uncategorized

Cambridge Healthtech Institute s 3rd Annual August 13-14, 2018

To ensure the quality, safety and rapid production of cell therapies, companies must keep on top of their CMC and analytical strateigies. However, cell-based therapies are extremely complex to analysis with high variability.

Cambridge Healthtech Institutes Cell Therapy CMC and Analytics meeting focuses on the technical and regulatory requirements needed to advance the analysis, quality and development of cell therapies with in-depth case studies and regulatory feedback on CMC development, product release, assay development and validation, flow cytometry, target product profiles, critical quality attributes, critical process parameters, and product release.

Final Agenda

Day 1 | Day 2 | Speaker Biographies

Monday, August 13

8:00 am Short Course Registration Open (Grand Ballroom Foyer) and Morning Coffee (Break Foyer)

11:30 Main Conference Registration Open (Grand Ballroom Foyer)

1:00 pm Chairpersons Opening Remarks

Fouad Atouf, PhD, Vice President, Global Biologics, USP

1:10 Cell Therapy Product Manufacturing Considerations

Bernadette Keane, PhD, Principal, Keane Consultancy

Cell therapies are substantially more complex than small molecule or biological approaches to medicine. This complexity poses challenges for both academic groups and companies developing cell therapies, as well as for regulators seeking to oversee this growing area of medicine. In this interactive session, we will discuss some of the common challenges and lessons learned along the way and explore how collaborations between industry and the regulators can help lead to successful translation and commercialization of cell therapies.

1:45 Regulatory Aspects of Manufacturing and Control of Genetically Modified Cells

Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

In respect to manufacturing and quality control, genetically modified cells are considered to be most complex medicinal products. Regulatory aspects considering the fundamental steps in manufacturing and control of these medicinal products will be presented, and the regulatory framework for these products which are classified in the EU as advanced therapy medicinal products and are regulated centrally by the European Commission and the European Medicines Agency will be given.

2:15 Standards and Best Practices Applicable for Advanced Therapies

Fouad Atouf, PhD, Vice President, Global Biologics, USP

Qualification of raw materials used in the manufacturing of cellular therapies, requires the use of risk assessment strategies to categorize the critical components of a manufacturing process. In addition to cell culture supplements, excipients and other formulations components must meet the required quality to ensure consistency in manufacturing and subsequently the quality and safety of finished cell therapy products. This presentation will discuss the critical strategies facing the development of cell therapies as per USP recommendations.

2:45 Refreshment Break (Foyer)

3:15 FDAs CMC Review of a Cell Therapeutics

William Lee, PhD, Vice President, Regulatory Affairs, Cato Research

This talk will focus on two case studies. The first case study will discuss FDAs CMC issues with a stem cell therapy that were raised at a pre-IND meeting. The second case study will discuss FDAs CMC questions for an investigational cell therapy during the pre-IND meeting and then subsequently during the IND 30-day review after initial IND submission.

3:45 PANEL DISCUSSION: Regulatory and CMC Strategies for Cell Therapies

Moderator:

Fouad Atouf, PhD, Vice President, Global Biologics, USP

Panelists:

Bernadette Keane, PhD, Principal, Keane Consultancy

Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

4:30 Breakout Discussions

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

Accelerating Cell Therapy Development

Moderator: Fouad Atouf, PhD, Vice President, Global Biologics, USP

Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

Bernadette Keane, PhD, Principal, Keane Consultancy

Commercial Manufacturing of Gene-Modified Cell Therapies: The Challenges Ahead

Moderator: Michael D. Jacobson, PhD., Managing Partner, Cambridge Biostrategy Associates

5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing (Grand Ballroom)

7:00 End of Day

Day 1 | Day 2 | Speaker Biographies

Tuesday, August 14

7:30 am Registration Open and Morning Coffee (Grand Ballroom Foyer)

7:55 Chairpersons Remarks

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

8:00 Tools and Strategies to Improve Confidence in Cell Counting Measurements

Laura Pierce, PhD, Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, NIST

Cell count, a routinely performed fundamental measurement in the biosciences, underpins key decisions in the manufacturing, commercialization, and release of cell-based therapies. The industry seeks tools to gain greater confidence in cell counting measurements. NIST, in collaboration with industry and other government agencies, is developing strategies to provide fit-for-purpose measurement assurance for cell counting, in the forms of written standards, experimental designs, and control materials.

8:30 Towards Rigor and Reproducibility in Single Cell Analytics for Therapeutic Cell Products

Ruud Hulspas, PhD, Independent Consultant, Cellular Technologies Bioconsulting, LLC

Cell characterization occurs at multiple checkpoints of the manufacturing process and is particularly important at product release. In contrast to bulk analysis, single cell analysis offers detailed information about the composition of therapeutic cell products. Flow cytometry provides rapid analysis of millions of cells for up to 30 cellular parameters, simultaneously measured on individual cells, but it can also be difficult, unreliable and expensive. Existing expertise and new developments are applied for successful integration in cell therapy.

9:00 Assays in Purification of Targeted Cell Populations

Patricia Rogers, Manager, Cell Sorting Capability, Broad Institute of MIT and Harvard

Cell purification of targeted populations is necessary when specific populations are needed for downstream applications. Instrumentation needed in order to purify cell populations is often complicated and hard to standardize. Also, there is biological variation between samples that needs to be accounted for. This presentation will focus on understanding the key areas for variation and developing tools to standardize each part of the assay in order to provide reproducible results.

9:30 Advancing Rapid Microbial Testing Methods for Cell-Based Therapies

Jacqueline Wolfrum, PhD, Associate Director, Biomanufacturing Program (BioMAN), Center for Biomedical Innovation, Massachusetts Institute of Technology

Cell therapy manufacturers need rapid microbial testing methods (RMTM) to provide evidence of process and product safety in timeframes relevant to the manufacturing process, product shelf life, and patient treatment protocol. The Standards Coordinating Body is driving a collaborative effort to meet this shared need for RMTM by identifying, developing, and validating needed standards and methods. Interested stakeholders are encouraged to participate in this project.

9:45 Coffee Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)

10:30 Potency Assay Development and Qualification for B-Thalassemia and Sickle Cell Disease Autologous Gene Therapy Drug Products

Ilya Shestopalov, PhD, Senior Scientist, Cellular Process Characterization and Analytics, bluebird bio

Quantitative potency assays were developed to demonstrate correction of b-thalassemia and sickle cell disease properties in an in vitro cell culture system. Potency was found to be specific to the beta-globin lentiviral vector and dependent on transduction efficiency of the autologous gene therapy drug product, demonstrating ability to reject sub-functional drug products. Considerations for assay development, qualification results, and redundancy to transduction efficiency methods will be discussed.

11:00 Product Release towards Rapid Quality Control

Junxia Wang, PhD., Director, Analytical Development, Mustang Bio, Inc.

As living drugs, cell therapies pose unique analytical characterization challenges; these challenges extend from the research bench to the cGMP manufacturing setting. This talk will review common analytical methods for cell therapies, specifically CAR T- and TCR-based therapies, with a specific emphasis on the limitations of current methods and the move towards automated analytical methods.

11:30 PANEL DISCUSSION: Automation in Analytics and Manufacturing

Moderator:

Rodney Rietz, PhD, Senior Investigator, Exploratory Immuno-Oncology, Novartis

Panelists:

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Junxia Wang, PhD., Director, Analytical Development, Mustang Bio, Inc..

Jacqueline Wolfrum, PhD, Associate Director, Biomanufacturing Program (BioMAN), Center for Biomedical Innovation, Massachusetts Institute of Technology

12:00 pm Single Cell Proteomics for Evaluating Function & Clinical Utility in Cell Therapy

Sean Mackay, CEO, IsoPlexis

By capturing 40+ secreted proteins per single cell, thousands of cells at at time, researchers can determine the functional activity and strength of immune cells and cellular products. Using the IsoCode technology to define T-cell functional strength, Kite Pharma has used their pre-infusion product to predict objective response to CAR-T therapy. Isocode technology has also provided biomarker correlates to objective response in checkpoint inhibitor therapy - both from TILs and PBMC.

12:30Enjoy Lunch on Your Own

1:15 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)

1:55 Chairpersons Remarks

Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC

2:00 Assessment of Comparability of a Gene Therapy Drug Product after Manufacturing Site and Process Changes

Stephen J. Duguay, PhD, Director, Cellular Process Characterization and Analytics, bluebird bio

Manufacturing site changes and process improvements were implemented during clinical evaluation of an autologous cell-based gene therapy. A risk based approach was used to rank the potential impact of the changes to product quality, safety and efficacy. Statistical evaluation of study results included equivalence testing, quality ranges and qualitative comparisons. The study design, results and conclusions will be discussed.

2:30 In vitro Product Characterization and Stability Studies of CAR T Cell Therapies

Carlotta Peticone, PhD, Senior Scientist I, Process Development, Autolus

3:00 How Much Information Do I Need to Present for the Vector of My Genetically Modified Cell Product?

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

How do regulatory agencies view the vector of a genetically modified cell? Does the vector need to be GMP; from what point in manufacture would this apply? Can I use a drug masterfile? How much information, including data, should I provide in the dossier for clinical trials; will this be different for approval?

3:30 Refreshment Break in the Exhibit Hall with 1st Session Poster Winner Announced (Grand Ballroom)

4:15 Designing Strategies for Data-Driven Product Characterization

Marc-Olivier Baradez, PhD, Lead Analytical Development Scientist, Cell and Gene Therapy Catapult

In the development of cell therapy products, the ability to characterize the product during its manufacture is becoming as valuable as the ability to control and optimize the process itself. This presentation will explain the current limitations and opportunities associated with such dual product/process characterization, and it will cover the principles behind a suitable data-driven strategy for efficient product/process development in the context of industrialization.

4:45 Big Data Strategies for Cell Therapy Manufacturing

Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC

The quest to retrieve, analyze, and leverage that data has become the new gold rush in life sciences. This presentation will discuss the role of big data in cell therapy process development, real time analytics and commercial scale manufacturing.

5:15 End of Conference

6:00 - 8:30 Recommended Dinner Short Course*

Day 1 | Day 2 | Speaker Biographies

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Cell Therapy CMC and Analytics - The Bioprocessing Summit

Stem Cell Therapy in Dallas, TX | Atlas Medical Center

By Stem Cell Medical Center

Stem Cell Therapy A Natural, Safe Alternative To Surgery

Stem cell therapy is a revolutionary regenerative treatment that uses your own mesenchymal stem cells from your fat cells (adipose cells) or from your bone marrow to help repair the damaged or degenerative cells in your joints and encourages healing. These procedures use state-of-the-art techniques that are very ethical and safe. All of our procedures follow the FDA guidelines for MINIMAL MANIPULATION (WE DONT ADD ANY ENZYMES OR CHANGE YOUR CELLS IN ANY WAY).

Mesenchymal stem cells from your fat OR bone marrow are also called adult stem cells, and they help facilitate the regeneration of tissue naturally in the joint. These stem cells are considered to be raw potential or multipotent meaning they can differentiate into the tissue cells needed in a specific area. These cells normally function alongside the immune system and work to replace skin and tissue when the body experiences trauma. Stem Cell Therapy takes that natural regenerative ability and focuses it on the region where your body needs help repairing itself. Mesenchymal stem cells direct cytokines and growth factors from your immune system to the targeted area to create an ongoing healing process as your body repairs itself organically. Research has shown that stem cells have the potential to repair damaged cartilage, bone, tendons, muscle, skin, and connective cell tissue.

The stem cells being used are from YOUR OWN BODY. This helps eliminate the potential for your immune system to reject the cells and also eliminates the potential for disease transmission. These are your own cells, concentrated and injected to perform the duties they were naturally created to execute. Stem cell therapy keeps you safe from the dangerous side effects of traditional joint condition treatment. Medications like NSAIDs and pain relievers carry high risks to your vital organs, and invasive surgeries to replace joints with prosthetics can lead to a list of adverse outcomes up to and including death. Adipose Stem Cell Therapy and Bone Marrow Stem Cell Therapy is minimally invasive leaving a narrow margin for complications and adverse reactions. Patients benefit from this procedure because it is administered by trained professionals, in a controlled environment in a same-day process.

In the PAST the devices used to aspirate bone marrow were considered VERY painful, time-consuming, and extremely invasive. In 2017, this all changed when a new proprietary device for bone marrow aspiration received FDA clearance. This new device is THE ONLY bone marrow aspiration device that has received FDA clearance that is virtually painless and is less invasive compared to other bone marrow aspiration methods.

Currently, Atlas Medical Center is the only office in the DFW Metroplex that has been trained to use this revolutionary device for aspirating bone marrow.

Once the cells are extracted, they are immediately injected directly into the joint or area that is injured. Once injected, the healing process begins, and the stem cells begin sending signals to your immune system to get to work repairing the damage. This is all performed under ultrasound guidance so that there is ZERO guesswork (and the provider can see in REAL TIME exactly where the injection needs to be injected).

Our patients have reported that the procedure is virtually PAINLESS. The procedure requires NO general anesthesia (just local), is considered very safe, is the least invasive, requires no downtime, no hospitalization, and has shown to yield more cells compared to any other method. The proprietary method Atlas uses allows you to be in and out of our office in 45 minutes to 1 hour.

Patients are literally shocked and amazed that they can walk right out of our office and continue their usual daily activities without a single stitch- just a band aid. For example, the difference in recovery time between knee surgery versus a stem cell therapy treatment is astounding. So many patients have avoided sacrificing half a year of their life recovering from surgery by choosing stem cell therapy that has you returning to work usually on the same day!

The adipose technique that our medical providers utilize is also a virtually painless process, compared to other older techniques.

Using a local anesthetic, our medical team will take a small sample of fat tissue from your buttock. This process is usually painless, but some patients experience a slight, minimal discomfort. Once your fat cells have been collected and processed using a powerful centrifuge, they are injected under ultrasound guidance into the area of injury.

This minimally invasive procedure can be completed in 2-3 hours. The good news is there is no hospitalization, and it is an outpatient procedure. Theres a period where patients feel sore. This feeling usually lasts for a couple of days to a week. Patients are totally awake during the treatment, and most patients return to normal activities the same day or within 24-48 hours.

When Mesenchymal stem cells from either your fat or bone marrow are injected into an affected joint/s, they start to work to potentially repair and replace the damaged tissue. These cells incorporate themselves into the damaged area and over time begin to improve the stability of the tissue and reduce any pain being caused by the damage. Because mesenchymal stem cells work with your immune system to heal, they can also have an effect on inflammation. By reducing and regulating the chronic inflammation responsible for many joint conditions, mesenchymal stem cells deliver patients a rapid decrease in pain. Stem cells have been integral in advancing treatments for degeneration in the bones and joints, damaged cartilage in joints, labral and labrum tears, meniscus tears, osteoarthritis, tendinosis and a wide range of other ailments involving the joints. Both Adipose-Derived Stem Cell Therapy and Bone Marrow-Derived Stem Cell Therapy use the natural renewing functions of stem cells in our bodies as a concentrated treatment that can be focused in a targeted area to achieve optimal healing results.

On average, many patients start noticing improvement as soon as four to six weeks from the treatment, and some patients have experienced a noticeable reduction in pain as soon as a few days after treatment. There is no need for time off of work for a lengthy recovery period like with invasive surgery, and many patients return to work on the same day of their procedure. We encourage you to take it easy while your body embarks on its healing process, but normal to moderate activity is okay. As with any medical treatment, not everyone is a candidate for adipose-stem cell therapy or bone marrow stem cell therapy, each patients response will vary so discussing options for your specific needs is key. On your consultation day, all of your questions will be answered, and our medical provider will let you know if you qualify for treatment.

Our purpose at Atlas Medical Center is to get you out of pain, improve mobility, and avoid having unnecessary surgeries. Our unique JointRenew Program is exclusive to the Atlas Medical Center. This advanced regenerative medical procedure uses a combination of two or more of the following: Stem Cell Therapy, Amniotic Cell Therapy, Cord Tissue Cell Therapy, Platelet Rich Plasma therapy, and Advanced Non-invasive laser therapy to optimize healing. Our clinical experience has shown that this combination accelerates healing; by allowing the greatest number of regenerative cells along with non-invasive technology to work together to potentially help regenerate the damaged area.

In addition, all of our medical providers are Board Certified, trained, and highly skilled in stem cell and regenerative cell procedures; and all injections are performed with ultrasound or fluoroscopy (real time x-ray). (This eliminates all guesswork so that the regenerative cells are injected precisely where they need to be.) This ensures that youre always receiving the best possible treatment and gives you the greatest chance for success!

Finally, our providers are currently the ONLY ones in the Dallas-Fort Worth Metroplex using the ONLY FDA cleared device to aspirate bone marrow for stem cell therapy that doesnt require any manipulation. This gives patients confidence in our providers knowing that they are following FDA guidelines.

Amniotic and Cord Cell Regenerative Therapy are alternative regenerative treatment for those who are not candidates for Stem Cell Therapy. Unlike bone marrow or adipose stem cell treatments, amniotic or Cord cell therapy is not health or condition dependent and offers those with arthritic joint conditions and soft tissue problems another treatment option.

For Dallas, Fort Worth or surrounding area patients, were located a short drive away in Irving and are looking forward to consulting with you.

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Stem Cell Therapy in Dallas, TX | Atlas Medical Center

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