Different clinical trials use varying dosage amounts (from a few million to 500 million!). The acceptable quantity is roughly 2 million mesenchymal cells per kg of body weight. Given an average weight of 70 kgs, it is estimated that 150 million menstrual blood derived mesenchymal cells will be sufficient for most transplants.
Stem cells are capable of expanding over 10,000 times. So should you need more cells, LifeCell can do additional expansion upon request.
The stored cells cannot be used directly for therapy as they have undergone only minimal expansion. It is not enough for a therapeutic dosage. When you need the cells for transplant, LifeCell at its own cost, will expand the cells and provide you 150 million mensenchymal stem cells. This process takes up to 90 days.
All clinical trials have their own guidelines, inclusion / exclusion criteria, based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study.
While the scientific support for cell based therapies is very strong, there is no assurance on the successful commercialization of these therapies. But the progress being made worldwide is very impressive, with several regulatory agencies giving the go ahead for development of stem cell based therapies. A few trials have also obtained fast-track development status from the USFDA.
Today, over 50 clinical trials using mesenchymal stem cells are underway in countries like the USA and Canada. Some have reached the stage III clinical trials as well. Finding potential uses for menstrual blood stem cells is still at a very early stage. However, there are all indications that these cells could be used in the treatment of various ailments like :
As of today, only the donor (that is you) can benefit from your menstrual stem cells. But chances are very high that it may also help genetically related family members in future.
Menstrual blood contains Mesenchymal stem cells. Menstrual Mesenchymal stem cells are unique because they are the only adult stem cell population that is shed regularly (during your periods), that multiplies in culture and can differentiate into other types of cells including heart, nerve, bone, cartilage and fat, according to early research. They can also be harvested in a totally painless, non-invasive and affordable way.
LifeCell meets the highest international quality standards. The company is a Good Manufacturing Practice/Good Tissue Practice Laboratory (CGMP/CGTP) facility, ISO 9001 and US FDA registered facility. It has successful accreditations from International Quality Management Organizations such as CAP (College of American Pathologists).
Stem cells have been cryogenically stored for more than 15 years, with no significant deterioration. You can reasonably expect the same, especially given that LifeCell maintains a state-of-the-art facility. Your menstrual stem cells will remain viable (ready for use) for several years, even indefinitely.
Once your sample is successfully processed and stem cells are preserved, we will send you a PRESERVATION CERTIFICATE confirming the storage of your sample along with a report stating the number of viable stem cells preserved. This generally takes about 6 weeks from the time of collection.
Your sample may get rejected if it has less than 2 million total nucleated cells or if the bacterial/fungal loads are higher than normal. The lab will inform you if your sample has been rejected. Your processing fee for Femme is non-refundable. However you can repeat your attempt to collect your menstrual cells. We also advice you to seek help from your gynaecologist to successfully collect your sample.
Upon receipt, the sample is first sterilized by treating it with antibiotics. Then the stem cells are isolated using a density gradient separation process. A portion of the cells are mixed with a cryo-preservation solution and stored. The remaining cells are subjected to an ex-vivo cell culture process for isolating a pure population of menstrual blood derived Mesenchymal stem cells. The stored cells are frozen through a controlled rate freezing process and maintained at below -150ÂºC for long term preservation.
Once our lab receives your Femme collection kit, your sample will be examined to see if it meets the acceptance criteria. If yes, it will be taken for processing. Processing usually takes upto 28 days to complete.
If for some reason, you've not been able to collect the sample properly, do let us know. We will send you another collection kit (at a charge). However, do speak to a gynaecologist who is familiar with the process and be familiar with the instructions before you start.
No. There is no known risk associated with collecting the menstrual blood sample.
For best results, the sample should reach us within 48 hours after collection. We will send you a convenient, pre-paid courier bill to dispatch the sample after collection. This is to ensure that there is no loss of time in transit. Alternatively you can contact our Customer Care or the local center who will ensure that the sample is dispatched to the laboratory.
Sometimes, a smaller sample may be enough. We can only tell you after our laboratory has received the sample and processed the same. For best results we suggest that you repeat the collection to the desired quantity before dispatching to our laboratory.
Period flow varies from woman to woman. You should collect your sample on the day of your heaviest flow. For some this could be the first day, for others the second. You are the best judge. Ideally, the sample should be 10 ml or more. This means, you should be wearing the menstrual cup for 3 to 4 hours.
Yes, in fact menstrual cups are far safer than tampons or pads. They are made of medical grade silicon, which is odourless and has anti-bacterial properties. It is latex free and BPA free. Moreover there is absolutely no risk of Toxic Shock Syndrome, like with tampons. The menstrual cup is used by thousands of women worldwide as an alternative to sanitary napkins and tampons.
After youâve enroled with us, call us as soon as you get your next period. We will send you a Femme menstrual blood collection kit, which has a step by step guide and all the necessary materials for a successful collection. You will need to collect your sample using the Hygina Menstrual Cup. You can do it comfortably in the privacy of your home.
While there is no expiry date on these stem cells, the law does not allow for perpetuity agreements of this nature. At age 60, you will have a good idea of your health and can take a decision regarding extension of storage.
No. We donât offer this service to women below the age of 18. We also advice you to opt for Femme as early as possible. For as you grow older, hormonal changes in your body could have a significant impact on the quality of stem cells stored.
Relax and celebrate! We will credit your account with the amount youâve paid for Femme. All you need to do is pay the balance to subscribe to LifeCellâs Baby Cord services to preserve your babyâs umbilical cord stem cells.
Age affects your body. It affects the quality of stem cells produced by your body. Between 25 and 40 years of age, you are at your prime. Investing in Femme during this time will help you collect a good quality sample of stem cells. Also hormonal changes in women, as they grow older, especially the onset of early menopause (peri-menopause) could have a significant impact on the quality of stem cells produced.
Subscribing to Femme is very simple and convenient. Please call our Customer Support Team at 1800-102-5757 or SMS 'FEMMEâ to 53456 or mail us at firstname.lastname@example.org. Our Customer Care Executives will get in touch with you, give you all the information and guide you through the enrolment process. Once you enrol, you will receive the Femme collection kit during your next periods. The menstrual blood collection can be done in the privacy of your home. Please follow the instructions provided in the kit box to collect the sample and send it to us.