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Frequently Asked Questions Biologics
Cell Preservation and Banking
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What are regenerative cells?
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Where are regenerative cells located?
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Is fat the best source of regenerative cells?
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What is regenerative cell preservation and banking?
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How are regenerative cells collected (harvested) and processed for banking?
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How are cells labeled for storage?
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How are cells preserved and stored?
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How much fat is needed to have enough cells to bank?
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How do you know the cells will be usable after thawing?
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What type of security system does MacroPore Biosurgery have for cell storage?
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Do I own my own regenerative cells?
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Can my cells be used for research will I be paid?
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What is the benefit of preserving and banking my own cells now?
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If I am diagnosed with an illness that would benefit from the use of my regenerative cells, could they be extracted at that time?
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Can my cells be used for another family member?
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I've decided to bank my cells what should I do next?
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What happens after my cells are banked?
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What if I do not have a surgeon?
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What are the fees for cell banking?
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What happens if I decide I don't want my cells to be used for research, after I've already said I do want them used?
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What are my options for discontinuing storage of my cells?
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What is the goal of regenerative cell research?
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What treatments are approved by the FDA?
What are regenerative cells?
A stem cell is an unspecialized cell that can become any of the hundreds of tissues that make up the body. Adult stem cells are found in various tissues after birth, whereas, embryonic stem cells are found in fetal tissue. Adult stem cells, or regenerative cells, are valuable because they offer a potential source of replacement cells to treat a variety of diseases and disorders, with the potential to help millions of people around the world.
MacroPore Biosurgery's efforts are exclusively directed toward autologous cell transplantation separating the cells from fat and giving them back to the same person. By using one's own cells, the recipient can avoid the problems of disease transmission and rejection associated with donor tissue.
Where are autologous cells located?
Regenerative cells are located in many tissues in the body. Some of these areas are difficult and/or painful to reach or do not yield a high number of cells, whereas, adipose (fat) tissue is easy to obtain through liposuction and offers a plentiful source of cells.
Is fat the best source of regenerative cells?
MacroPore Biosurgery believes fat is the best source of regenerative cells because of the quantity, as well as quality of the cells. In comparison to bone, muscle, blood, brain or liver tissue, fat is both expendable and accessible.
What is regenerative preservation and banking?
Typically arranged through the patient's physician, regenerative cell banking is the process by which cells, taken from a liposuction or other procedure, are stored (cryopreserved) in a liquid nitrogen freezer at -320°F (-196°C), exclusively for the patient who banked them. Frozen in suspended animation, the cells can be stored and kept safe at our state-of-the-art facility for the life of the individual
MacroPore Biosurgery is offering the opportunity for surgical patients to bank their cells for future use. The first of its kind in the world, our cell preservation and banking facility is a California state-licensed tissue bank.
How are regenerative cells collected (harvested) and processed for banking?
Regenerative cells are harvested from the waste fat tissue. The tissue collection is completed by a plastic surgeon in the surgeon's office or clinic during a liposuction or other procedure.
Prior to the surgical procedure date, MacroPore Biosurgery provides the physician with the necessary materials to collect the fat tissue during the liposuction procedure. The tissue is collected in our proprietary collection system. This system is composed entirely of medical grade materials and remains sterile from collection through processing and cryopreservation.
The surgeon labels the tissue collection device with the patient's identification at the bedside at the time of the procedure. After the liposuction, the collected tissue is sealed in a special container and placed in a shipping package with frozen gel packs for the overnight return to our California facility. The frozen packs keep the cells cold and alive during the overnight transport.
After careful inspection, to make certain that it was packaged and shipped properly and safely the tissue is then processed and the cells are prepared for freezing.
How are cells labeled for storage?
The labeling and banking process is based on industry-recognized techniques developed by blood banking institutions. Once the cells arrive at our facility, adhesive bar code labels and a fully integrated bar code system tracks the cells throughout processing and into storage. The labels have special adhesive that can withstand freezing in liquid nitrogen at -320°F (-196°C). Additionally, our labeling system identifies you by a specific bar code, which serves to protect your privacy.
How are the cells preserved and stored?
Cells are preserved (cryopreserved) in a liquid nitrogen storage freezer at a temperature of -320°F (196°C) at our state-of-the-art facility. Packaged in specially designed four-pack units, the cells can be accessed independently for up to four times by the patient. The ultra-cold temperature preservation allows cells to be used for the life of the patient.
This process does not rely on electrical power evaporating nitrogen maintains the temperature, and keeps the cells cold without using any power. As a result our storage freezers will keep the cells cold even if the power is out for days.
How much fat is needed to have enough cells to bank?
The amount varies, depending on the person. We can process as little as 4 ounces of fat tissue (100 cc), or as much as 2 pounds (1.2 liters).
How do you know the cells will be usable after thawing?
Our proprietary procedures have demonstrated that the cells can be successfully frozen and thawed. Thawed cells have shown that they have all the same properties they had before they were frozen; that is they can grow and proliferate, and can form many different tissue types.
What type of security system does MacroPore Biosurgery have for cell storage?
Although we do not publicly disclose the full nature of our security systems, we have had our facility secured by a professional security company. A wide array of detectors and alarms are installed throughout our facility, and access to the cell processing and storage laboratories is restricted.
Do I own my own regenerative cells?
Yes. However, you have the choice of releasing ownership of 10% of your cells for use in research-related activities. This gives MacroPore Biosurgery and our research collaborators access to the cells to continue with development of new clinical uses.
Can my cells be used for research will I be paid?
With your permission, 10% of the cells harvested would be used for research. These cells become anonymous to the researchers. The remaining 90% will be yours and kept for you.
Several of our banking programs include 5 years of storage. If you give us permission to use 10% of your cells for research purposes you get an additional five free years of storage. There will be no other payment for the donated cells.
The portion of your regenerative cells that you allow us to use for research and any non-cellular by-products of cell banking will be owned by MacroPore Biosurgery. If a commercial product is developed from this material, the commercial product will be owned by MacroPore Biosurgery or its designee. The individual will not profit financially from such a product.
What is the benefit of preserving and banking my own cells now?
There are several advantages to preserving cells in advance of need. These advantages include both practical and scientific issues.
For example, if a person waits until he becomes a medical patient in need of the cells to help restore or regenerate his own tissue, a liposuction procedure would need to be done at the time when the patient may already be undergoing other procedures or treatments for the medical condition.
Our research, confirmed by several independent studies (D'Ippolito et al, 1999; O'Driscoll et al, 2001; Muschler et al, 2001) has shown that cell number and function decline as a person ages. The ultra-cold temperature preserves the cells in such a way that the aging process is suspended, allowing the cells to retain the function and activity they had on the day they were collected.
Currently, the limits of these cells are not known. We do know adipose derived cells have demonstrated the ability to differentiate into different types of tissue such as cartilage, fat, nerve, bone and muscle in vitro.
The potential benefits of regenerative cells could encompass a variety of medical applications. Active areas of research include: fracture healing, osteoporosis, arthritis, reconstructive and cosmetic surgeries, and diseases such as, Parkinson's or Alzheimer's and for spinal cord injury.
If I am diagnosed with an illness that would benefit from the use of my regenerative cells, could they be extracted at that time?
Possibly. However, in addition to whatever procedures and drugs you would be given for your illness you'd also have to undergo a separate procedure.
Can my cells be used for another family member?
While it is possible to transplant these cells from one person to another, the risk of side effects such as rejection and transmission of infectious disease or genetic disorders is high. For this reason, MacroPore Biosurgery's policy is that we will only store cells that are exclusively intended for use in the person from whom they were taken (or only for "autologous use"). There is no better source of cells than your own body.
I've decided to bank my cells what should I do next?
Once you have made the decision to bank your cells, the banking service can be arranged through your surgeon. The surgeon will provide a Patient Enrollment Package, which you can complete in the surgeon's office. The Enrollment Package also includes consent forms for MacroPore Biosurgery to process and store your cells.
What happens after my cells are banked?
Upon completion of the preservation and banking process, MacroPore Biosurgery will send you a Client Banking Card. This will confirm that your cells are safely stored and provide the telephone numbers for MacroPore Biosurgery. Typically the physician or hospital would notify MacroPore Biosurgery when the patient's cells would need to be used by the patient. In the event that you would want your cells stored at a different location you would need to contact us directly.
What if I do not have a surgeon?
MacroPore Biosurgery does not perform cell harvest procedures, does not practice medicine, and does not endorse or recommend specific surgeons or surgical procedures for patients. A Physician Directory provided in the Patient Information section of our web site lists physicians, by state and zip code, who offer their patients cell preservation and banking options.
What are the fees for cell banking?
The fees for collecting, processing, and banking your cells depend on your case and your surgeon. Several options are available with varying fee schedules. An initial fee is charged for tissue collection, processing and preservation, which may also include the first 5 years of storage. If you choose, you may allow us to use 10% of your cells for research purposes. In return, we will provide 5 additional years of storage at no charge.
Alternate programs have a lower initial fee with annual storage fees beginning after the first year. This option is not eligible for the 5 year extension for research donation.
What happens if I decide I don't want my cells to be used for research, after I've already said I do want them used?
Let us know immediately by calling 1-800-783-6099. You must call us before your cells arrive at our banking facility the morning after your surgical procedure. If you call after that time it may be too late and your cells may have already been assigned for research.
At the time of your call, we will also ask you to confirm your withdrawal request in writing. This ensures we correctly bill you for cell storage fees.
What are my options for discontinuing storage of my cells?
You must provide us with a written statement that you wish to discontinue storage, and designate what you want done with the stem cells. Your options include offering all of the cells for research, having all of the cells discarded, or having the cells transferred to another storage facility. If you provide an address, we will send the cells anywhere you designate. You will be responsible for the cost of shipping.
What is the goal of regenerative cell research?
The main goal of regenerative cell research is to advance the healing or regeneration of organs or tissues damaged by disease, age, or trauma. The following tissues are just some of the areas being investigated by cell therapy researchers:
- Heart for heart attacks and heart failure
- Bone for treating fractures and conditions of bone loss
- Fat for facial rejuvenation, reconstructive surgery, and incontinence
- Disc for disc regeneration in the spine
- Nerve for nerve and brain disorders
- Cartilage for joint arthritis and injury
Currently, MacroPore Biosurgery's efforts are focused on separating the regenerative cells from fat and giving them back to the same person for therapeutic treatment. In addition, by using one's own cells, the recipient can avoid the problems of disease transmission and rejection associated with donor tissue.
What treatments are approved by the FDA?
Although cell research is still in its infancy it has received a lot of press coverage due to the enormous potential of cells to cure many diseases. Currently there are no treatments approved by the FDA, but many clinical trials are in process.
For more information regarding clinical trials please view the information on the following web sites:
www.centerwatch.com An information source for the clinical trials industry. Type "stem cells" in the search field.
www.clinicaltrials.gov The U.S. National Institutes of Health, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies. Type "stem cells" in the search field.
References
D'Ippolito G, Schiller PC, Ricordi C, Roos BA, and Howard GA: Age-related osteogenic potential of mesenchymal stromal stem cells from human vertebral bone marrow. J Bone Miner Res 14: 1115, 1999.
Muschler GF, Nitto H, Boehm CA, and Easley KA: Age- and gender-related changes in the cellularity of human bone marrow and the prevalence of osteoblastic progenitors. J Orthop Res 19: 117, 2001.
O'Driscoll SW, Saris DB, Ito Y, and Fitzimmons JS: The chondrogenic potential of periosteum decreases with age. J Orthop Res 19: 95, 2001.
Please Note:
MacroPore Biosurgery does not perform cell harvest procedures, does not practice medicine, and does not endorse or recommend specific surgeons or surgical procedures for patients. MacroPore Biosurgery, Inc., the publisher of this web site, makes no representation, guarantee, or warranty (express or implied) as to the medical ability, competence, or quality of treatment, which may be provided by any of the doctors or medical centers which are listed herein.
MacroPore Biosurgery, Inc., also makes no representation regarding the status of the listed doctors as certified specialists in the areas of medical practice listed herein. Moreover, MacroPore Biosurgery, Inc., expressly denies liability and undertakes no responsibility for the results or consequences of any medical treatment provided by any of the doctors or medical centers listed in this web site.
The information contained in the web site is educational only and should not be construed as offering medical advice.
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