Why Bank Cord Blood Stem Cell?

Much attention has been focused recently around the world in the role of stem cells in the potential treatment of disease conditions. In the foreseeable future, it may be possible to use stem cells to rebuild or regenerate damaged or diseased tissues and organs. At present, stem cells are being used primarily to replace bone marrow depleted or destroyed by disease or chemotherapy.

Collecting Cord Blood offers a once-in-a-lifetime opportunity to obtain stem cells. Cord blood can only be collected during birth. It will no longer available after the placenta is delivered. What are the importances of storing stem cells from cord blood?

1.	Protect your family
	Many expectant parents are storing their baby’s cord blood for their family as “biological insurance” in knowing these precious stem cells may someday be useful for their children, themselves or other family members.
2.	Painless, Non-Invasive, and Risk-Free Retrieval
	Technically a simple collection process which takes only a few minutes and collected safely without maternal or neonatal risk following delivery.
3.	Family Medical History
	Families with medical history of developing diseases that are potentially treatable with stem cell transplants, including diseases such as leukemia and immune system disorders.1 The highest probability for a transplant match is from a related donor. In addition, the transplant success rate of related donors is double that of unrelated donors.2
4.	Compatibility and Accessibility
	Finding a compatible cord blood unit remains an important consideration for patients. Locating a suitable match from public registries can be difficult and is often time-consuming. In fact, more than 30% of patients requiring transplant therapy are unable to find a suitable match.3 The statistical likelihood of finding a suitable donor decreases for children of ethnic or racial minorities or adopted children. For these families, private cord blood banking improves the likelihood that a suitable transplant will be immediately available. Otherwise, without a privately banked unit, a search could take months and still be unsuccessful.
5.	Immediate Availability for Clinical Use
	The stem cells are ready for use after thawing, hence eliminating the hassle of searching for a matching donor’s stem cells.
6.	Lower Collection Fee
	Significantly lower cost compared to bone marrow aspiration and bone marrow transplant.
7.	100% Perfect Match
	The baby’s cord blood stem cells guarantee a perfect match for the baby and can potentially match with their siblings and parents.
8.	Less stringent HLA (human leukocyte antigen) matching is required for use in transplantation as compared to bone marrow.
9.	Low Rejection
	low chances of life threatening Graft versus Host Disease (GVHD) after transplantation.

1. Hayani A. et al. First Report of Autologous Cord Blood Transplantation in the Treatment of a Child with Leukemia. Official Journal of the American Academy of Pediatrics. 2007:296-300
2. Gluckman, E. et al. Outcome of cord-blood transplantation from related and unrelated donors. Eurocord Transplant Group and the European Blood and Marrow Transplantation Group. 1997 Aug 7;337(6):373-81
3. Wagner, J., et al: Blood 2000 (5):1611-1618

Banking Stem Cells

Re “Questioning the Allure of Putting Cells in the Bank” (Jan. 29):

I am an eight-month survivor of a double-cord bone marrow stem cell transplant. I might not be alive if these cord cells were not available from banks in Australia and France. Clearly, I am grateful to the mothers who saved this cord blood, so you can only imagine what I think of the advice to not bank cord blood to save lives around the world. If the problem is the cost to the donor and scaremongering by the banks, then that is the issue that needs to be addressed.

Noel Beninati
Ballston Spa, N.Y.

Sacramento Boy Undergoes Stem Cell Procedure

Reporting
Kris Pickel

SACRAMENTO (CBS13) ―  All we seem to hear about is the controversy surrounding stem cells, but do you know what they can actually do? A Sacramento boy suffering from an incurable condition may be living proof that stem cells can have remarkable results.

The little boy you are about to meet is one of the first in the nation to undergo stem cell treatment for his condition.

Dallas Hextell cries like many toddlers do, but he is different. It’s his only form of communication.

“You just want him to be better. You just wish you could fix it and take it away but you can’t,” Dallas’ mother Cynthia told CBS13’s Kris Pickel.

Excited over their first born, it didn’t take long for Cynthia and Derek Hextell to suspect something was wrong with baby Dallas.

“He didn’t open his eyes. He just cried a lot and they kept saying it was colic,” explained Cynthia.

Feeling her concerns were being ignored, Cynthia switched pediatricians. At 8 months old, they were referred to a neurologist who within 15 minutes diagnosed Dallas with Cerebral Palsy. Cerebral Palsy is damage to the brain, affecting muscle control.  There is no cure, only treatments to help manage the debilitating effects.

“You can tell he’s frustrated because his mind is healthy and he want to do things physically. He just can’t.” said mom Cynthia.

At 18 months old, Dallas’ physical development was closer to an 8 month old. He has trouble with hand control and can’t wave or clap or crawl. He doesn’t talk or even babble. He just screams. Sad screams. Frustrated screams. Even happy screams.

Dallas ‘ parents hope their decision to bank his umbilical cord blood will give him a shot at a normal life. Because Dallas has access to his own stem cells, he’s been accepted into a clinical trial at Duke University.

The family recently flew to Duke for a procedure where Dallas’ stem cells are put back into his blood stream in hopes they will find their way to the damaged tissue in his brain and repair those cells.

After the procedure, Dallas and his family came back to Sacramento to wait and see if the expensive treatment would pay off. They didn’t have to wait long.

Just 5 days after the procedure, Dallas said his first word “momma”. That was quickly followed by learning to wave and even laughing.

“That’s the best feeling in the world to hear your little kid laugh,” said Dallas’ dad Derek. “He had never laughed before.”

Three months after the treatment, the little boy who didn’t have the muscle control to crawl is now scooting all over without using a walker. He also looking at his parents when they talk to him.

While there is no way to know if or how much the improvements are directly related to the treatment, Dallas is for the first time making amazing strides forward instead of falling further back.  

Cord blood stem cells are now being used to treat dozens of medical conditions from heart disease to leukemia. But banking cord blood is not cheap. The cost is about $2,000 initially and then $100 every year after that in storage costs.

(© MMVIII, CBS Broadcasting Inc. All Rights Reserved.)

Dallas Hextell has show amazing improvement since undergoing an experimental stem cell procedure for his Cerebral Palsy. CBS

Umbilical cord blood can help metabolic disorders

Mon Dec 10, 2007 12:42 PM ET WASHINGTON (Reuters) - Umbilical cord blood transplants, even from unrelated donors, can help save the lives of babies born with certain inherited metabolic disorders, U.S. researchers reported on Monday. Usually, bone marrow transplants are the only option for such infants, who can die from organ failure and early death. Bone marrow transplants can be difficult to get and donors are rare. Umbilical cord blood, however, can be donated with every birth and also contains immature cells known as stem cells that can restore missing or damaged cells in a patient. Stem cells are the body’s master cells and there are several kinds. Stem cells from the bone marrow or cord blood are partly differentiated, or transformed, and can be used to restore the immune systems of patients undergoing cancer treatment, for example. Dr. Vinod Prasad and colleagues at Duke University in North Carolina studied 159 children with inherited metabolic disorders who received transplants of cord blood from unrelated newborns at Duke between 1995 and 2007. “We saw that there were advantages to the unrelated cord blood transplant,” Prasad said in a statement. “For instance, cord blood is more readily available than bone marrow and there was a decreased risk of complications, including a lower incidence of serious and potentially fatal graft-versus-host disease, which occurs when donor cells perceive a recipient’s tissues and organs as foreign.” Speaking to an American Society of Hematology meeting in Atlanta, Prasad said more than 88 percent of patients who got cord blood transplants before they began to show too many symptoms of illness lived for at least a year. “One reason for this could be the cord blood cells are immunologically more naive than the blood-forming stem cells derived from bone marrow and therefore they may be more adaptable and less reactive once they get into the patient’s body,” he said. One metabolic disease Prasad’s team treated is Krabbe disease, also known as Krabbe leukodystrophy, which affects the nervous system. Another is Hurler disease, which affects the heart, liver and brain. “These disorders are rare when taken individually — some of them occur in only one in a million births — but if you put them together they have a sizable incidence, maybe 1 in 10,000 births,” Prasad said. (Reporting by Maggie Fox, editing by Will Dunham and Sandra Maler)

© Reuters 2007. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Adipose-Derived Stem Cells Show Promise in Breast Reconstruction

 Results Reported at the 30th San Antonio Breast Cancer Symposium -December 15, 2007, San Diego, CA - Cytori Therapeutics (NASDAQ: CYTX) received results from an independent, investigator-sponsored study in Japan in which adipose tissue-derived stem and regenerative cells were used for breast reconstruction following partial mastectomy. The study data were presented today at the 30th San Antonio Breast Cancer Symposium (Poster #4071).

The novel procedure evaluated 21 women with no metastases or recurrence at least one year after partial mastectomy. Among key findings:

• The procedure was reported safe and well tolerated in all women
• No rejection or immune response was observed
• Patient satisfaction of the outcome was 79 percent, with a mean follow up period of 7.7 months
• There was a statistically significant improvement in average breast tissue thickness at one month following treatment and at final assessment compared to baseline
• There was no significant loss of tissue thickness between one month and the final assessment

In the study, tissue loss resulting from partial mastectomy was reconstructed with each patient’s own liposuctioned fat, which was combined and enhanced with her own adipose-derived stem and regenerative cells. These cells were made available at the time of surgery using Cytori’s investigational device, the Celution™ System.

“This clinical series is an exciting, early development for women with breast cancer who undergo partial mastectomy,” said Marc H. Hedrick, M.D., president for Cytori Therapeutics. “The reported data suggest this novel procedure can be safely performed, is clinically practical for surgeons to implement, and confirms Cytori’s decision to initiate clinical trials intended to establish efficacy, ascertain volume retention, and measure the magnitude of aesthetic and functional improvement.

“Reconstructive options have not kept pace with the development of new cancer therapies and existing reconstructive options for women are either ineffective, impractical or both. Until now, partial mastectomy patients have had little hope other than to live with tissue loss. This procedure holds the potential to offer women the opportunity to restore the contour, volume and function lost during cancer treatment.”

Two clinical studies will be initiated next year in Europe by Cytori to further evaluate adipose-derived stem and regenerative cells, processed with the Celution™ System, in breast reconstruction following partial mastectomy. One study, RESTORE II, will evaluate up to 70 patients at multiple trial sites. A second study, VENUS, will be a 20-patient single center study in patients with more severe radiation damage and contour defects.

Fat, known medically as adipose tissue, is one of the body’s richest and most accessible sources of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve volume retention and graft persistence. For this reason, these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes when applied to cosmetic and reconstructive surgery.  

More than one million women worldwide are diagnosed with breast cancer annually, including more than 370,000 women in Europe and more than 240,000 in the United States. Due to continual advancements in cancer detection, a growing percentage of women are eligible for partial versus full mastectomies. Unfortunately, partial mastectomy often results in significant skin damage, tissue loss, pain, and reduction or loss of motion. Women who undergo such procedures have limited reconstructive options to potentially reduce associated pain, reverse loss of motion, and restore breast volume and contour.  

Cytori Therapeutics

Cytori Therapeutics’ (NASDAQ: CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients’ adult stem and regenerative cells. To reach its goal, Cytori is developing its innovative Celution™ System to separate and concentrate a patient’s own adult stem and regenerative cells from adipose (fat) tissue for these cells to be delivered back to the patient during the same surgical procedure. The Celution™ System will be introduced in 2008 in Europe for reconstructive surgery and launched in Japan for cryopreserving a patient’s own stem and regenerative cells. Clinical trials are ongoing or planned in cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com

Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and prospects of our business, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties, dependence on performance of third parties, and other risks and uncertainties described (under the heading “Risk Factors”) in Cytori Therapeutics’ Form 10-K annual report for the year ended December 31, 2006. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

Contact:
Tom Baker   
858-875-5258   
tbaker@cytoritx.com

Cardiac Stem Cell Therapy Closer To Reality

ScienceDaily (Dec. 30, 2007) — Since the year 2000, much has been learned about the potential for using transplanted cells in therapeutic efforts to treat varieties of cardiac disorders. “Cardiac stem cell therapy involves delivering a variety of cells into hearts following myocardial infarction or chronic cardiomyopathy,” says Amit N. Patel, MD, MS, director of cardiac cell therapy at the University of Pittsburgh Medical Center and lead author of an overview and introductory article, Cardiac Stem Cell Therapy from Bench to Bedside. “Many questions remain, such as what types of cells may be most efficacious. Questions about dose, delivery method, and how to follow transplanted cells once they are in the body and questions about safety issues need answers. The following studies, contribute to the growing body of data that will move cell transplantation for heart patients closer to reality.”

According to Patel, special editor for this issue, suitable sources of cells for cardiac transplant will depend on the types of diseases to be treated. For acute myocardial infarction, a cell that reduces myocardial necrosis and augments vascular blood flow will be desirable. For heart failure, cells that replace or promote myogenesis, reverse apoptopic mechanisms and reactivate dormant cell processes will be useful.

“Very little data is available to guide cell dosing in clinical studies,” says Patel. “Pre-clinical data suggests that there is a dose-dependent improvement in function.”

Patel notes that the availability of autologous (patient self-donated) cells may fall short.

Determining optimal delivery methods raise issues not only of dose, but also of timing. Also, assessing the fate of injected cells is “critical to understanding mechanisms of action.”

Will cells home to the site of injury? Labeling stem cells with durable markers will be necessary and new tracking markers may need to be developed.

Improved cell survival drugs

Adult bone marrow-derived mensenchymal stem cells (MSCs) have shown great signaling and regenerative properties when delivered to heart tissues following a myocardial infarction (MI). However, the poor survival of grafted cells has been a concern of researchers. Given the poor vascular supply after a heart attack and an active inflammatory process, grafted cells survive with difficulty. Transmyocardial revasularization (TMR), a process by which channels are created in heart tissues by laser or other means, can enhance oxygenated blood supply.

“We hypothesized that using TMR as a scar pretreatment to cell therapy might improve the microenvironment to enhance cell retention and long-term graft success,” said Amit N. Patel, lead author of a study titled Improved Cell Survival in Infarcted Myocardium Using a Novel Combination Transmyocardial Laser and Cell Delivery System. “TMR may act synergistically with signaling factors to have a more potent effect on myocardial remodeling.”

Patel and colleagues, who used a novel delivery system to disperse cells in the TMR-generated channels in an animal model, report significant cell survival in the TMR+Cell group versus Cells or TMR alone. The researchers speculated that there was an increase in local production of growth factors that may have improved the survival of transplanted cells.

Stem cells depolarize

Recent studies have suggested that there are stem cells in the heart. In this study, researchers engineered mesenchymal stem cells (MSC) to over express stromal cell-derived factor-1 (SDF-1), a chemokine.

“Our study suggests that the prolongation of SDF-1 expression at the time of an acute myocardial infarction (AMI) leads to the recruitment of what may be an endogenous stem cell in the heart,” says Marc Penn, MD, PhD, director of the Skirball Laboratory for Cardiovascular Cellular Therapeutics at the Cleveland Clinic Foundation. “These cells may contribute to increased contractile function even in their immature stage.”

In the study titled SDF-1 Recruits Cardiac Stem Cell Like Cells that Depolarize in Vivo, researchers concluded that there is a natural but inefficient stem cell-based repair process following an AMI that can be manipulated through the expression of key molecular pathways. The outcome of this inefficient repair can have a significant impact on the electrical and mechanical functions of the surviving myocardium.

Grafting bioartifical myocardium for myocardial assistance

While the object of cell transplantation is to improve ventricular function, cardiac cell transplantation has had limited success because of poor graft viability and low cell retention. In a study carried out by a team of researchers from the Department of Cardiovascular Surgery, Pompidou Hospital, a matrix seeded with bone marrow cells (BMC) was grafted onto the infarcted ventricle to help support and regenerate post-ischemic lesions.

“Our study demonstrated that bone marrow cell therapy associated with the surgical implantation onto the epicardium of a cell-seeded collagen type 1 matrix prevented myocardial wall thinning, limited post-ischemic remodeling and improved diastolic function,” says Juan Chachques, MD, PhD, lead author for Myocardial Assistance by Grafting a New Bioartificial Upgraded Myocardium (MAGNUM Clinical Trial): One year follow-up.

“The use of the biomaterial appears to create a micro atmosphere where both exogenous and endogenous cells find an optimal microenvironment to repair tissues and maintain low scar production,” explains Chachques.

According to Chachques, the favorable effects may be attributed to several mechanisms. The BMC seeded in the collagen matrix may be incorporated into the myocardium through epicardial channels created at the injection sites. Too, the cell-seeded matrix may help prevent apoptosis.

“This biological approach is attractive because of its potential for aiding myocardial regeneration with a variety of cell types,” concluded Chachques.

Those cell types include skeletal myoblasts, bone marrow-derived mensenchymal stem cells, circulating blood-derived progenitor cells, endothelial and mesothelial cells, adipose tissue stem cells and, potentially, embryonic stem cells.

The full research articles are published in Cell Transplation (Vol.16 No. 9).

Adapted from materials provided by Cell Transplantation.

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What are Cord Blood Stem Cells then?

Cord blood, also known as umbilical cord blood, is rich in hematopoietic stem cells. Cord blood is collected after the umbilical cord has been detached from the newborn, and utilized as a source of stem cells for transplantation.All of the cellular components of the blood including red blood cells, white blood cells and platelets are derived from hematopoietic stem cells.Beginning in the late 1980s, following a successful sibling-donor transplant, cord blood stem cells have been used to treat a number of blood and immune system related genetic diseases, cancers and disorders.Cord blood transplantation is considered by some in the industry to be Less Risky, Readily Accessible, More Effective and More Cost Efficient than Bone Marrow.Other points to consider are:

1. Perfect match for the child; siblings have a 25% chance of being an exact match. Parents and relatives are a potential partial match.
2. Less Stringent HLA matching required for use in transplantation.
3. Lower incidence of Graft-Versus-Host-Disease (GVHD) after transplantation.
4. Cord blood collection is simple, non-invasive, and is neither risky nor painful to mother and child.
5. Stored samples are immediately available when needed.

No longer a biological waste product!!!
“Today, stem cells are being used to treat nearly 70 blood disorders; Tomorrow countless more.”

What to look for when choosing a centre for your various stem cell services?

There are in fact, an enormous variation in the quality of services provided of which the most important is how are the stem cells processed and stored. The classification of the laboratories (class 100, class 1,000, class 10,000) are in placed to process your stem cells so as to ensure that your stem cells would not be at risks of contamination, the standards of equipment and the expertise of the personnel involved. We will break down the important factors for you to look out for when choosing a credible and reliable stem cell processing and storage facilities. These factors will determine the viability of your processed and stored stem cells when the time comes for you to utilize it. What is the use if at the time of need, you are told that your stem cells cannot be used due to contamination.Look out for the following:

1. Qualified, well trained and ethical laboratory staff
   • This is to ensure that your stem cell is handled in the correct manner.
2. 24 hour professional customer service
3. Affiliation with insurance companies and hospitals
4. Accreditation by AABB and ISO Certified
   • These accreditations ensure that your samples are processed according to the proper standards set by these bodies.
5. Compliance to current Good Manufacturing Practice (cGMP) standards
   • Laboratories must have class 100 clean room for the processing of your stem cells to minimize the risk of contamination during processing. Some companies might claim that they are processing under class 100 by using an equipment called a laminar flow. However, GMP standards require the laminar flow also to be housed in a room which is class 100.What is a class 100 clean room?
     Normally we breathe in more than a million air particles. A class 100 clean room has less than 100 air particle counts. Ask to visit the laboratory. You should be able to see many air filters called the HEPA filters (at least 8 and above on the ceilings) on the ceiling to ensure that the room is properly filtered to fulfill the class 100 requirements. Do not allow the company to give you excuses that for whatever reasons you cannot visit their laboratories.

     If a company stores your stem cells in vials, a class 100 clean room is a definite requirement to ensure that the stem cell is not contaminated. During processing, when the stem cell after being isolated will be partially exposed when they are being injected into the vials.

     It is your right to ensure how your stem cells are processed and stored so that if you do need back for whatever reasons, it is still viable.

   • Dedicated cord blood collection bags to maximise the amount of cord blood collected and this would lead to more stem cell after processing.
   • Good processing protocol (method) to ensure the maximization of stem cell recovered.
   • Good cryopresevation (freezing) protocol with proven bags for freezing. Some bags might burst during freezing if they are of inferior quality.
6. Process and store ONLY stem cells in dedicated facilities (no mixing of human and non-human tissue, no mixing of non-stem cell tissues)
7. International Independent Qualified and Respectable Medical Advisory Board
8. Quality, prompt and value-added service
9. Proven technology
10. Financial stability
11. Hospital or obstetrical caregiver programs
12. Automated processing technology being adopted and deployed to maximize the recovery of stem cells. At StemTech, we utilized the AXP AutoXpress™ Platform is the industry’s first functionally-closed, automated and sterile cord blood processing technology that consistently and efficiently harvests the stem cell from umbilical cord blood.We have a consistently high stem cells recovery rate. This means that StemTech saves more cells for your baby and family, which is important when you ever need them. A higher stem cells volume is always linked to improved treatment success. This system also offers low risk of contamination to your stem cells.

    We are the first stem cell bank in Malaysia to offer a next generation technology for processing cord blood,  Which is similar to the technology adopted by the world’s largest public and private family cord blood bank -  The New York Blood Center and Cord Blood Registry.

What are Stem Cells?

Stem cells are the body’s ‘master’ cells that can transform into different cell types including skin, bone, blood, nerve and muscle cells. Like actors awaiting casting call, stem cells wait for signals to tell them what to become. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function.Stem cells are commonly found in bone marrow, peripheral blood and umbilical cord blood.