Menstrual Stem Cell Banking by LifeCell India

Note to Indian Women: If you're having your period this week, you're probably an immediate target for LifeCell India.

One of the latest news articles to come out of Chennai this week is LifeCell India's announcement that they will be offering menstrual blood cell banking at their facility, adding to the cord blood business.

Personally, I think that most asian women would find this quite disgusting (and disturbing!) given that there are far more hygenic sources. What do you think?

The new service which commences on the 8th of March (Sunday) and apparently designated "Women's day" will be the launch, though I wonder how exactly one would launch a service like this.

LifeCell India signed on to license the technology from Cryo-cell which sent letters to all cord blood stem cell banks around the world (or at least they were courteous to send one my way) inviting any interested parties to license the technology which they were probably going to charge six to seven figures for.

Ironically, with the difficulties of obtaining parents to bank cord blood stem cells, LifeCell India seems unperturbed by the fact that menstrual cells are not even a proven source of stem cells and that culturally, there would be no objections.

"The limited availability of bone marrow led to the discovery of cord blood stem cells. Now it is proved that the success rate of menstrual blood stem cells is about 100 times higher than the 0.2 to 0.3% of stem cells derived from human bone marrow," said Mayur Abhaya, executive director, Lifecell International.

I'm a little skeptical about these statements, though to be fair I haven't read any scientific literature describing menstrual blood contents. But why would the body waste precious stem cells in menstrual blood? One can understand baby's cord blood, as that is blood that circulates through the placenta and the baby's developing blood system, but cells that are meant to be shed are probably already hormonally directed down a self-destruct pathway.

"These stem cells are unique because they multiply rapidly and can differentiate into many other types of cells such as neural, cardiac, bone, fat, cartilage etc," said Dr Ajit Kumar, chief scientific officer, LifeCell International. They can be used to treat everything from heart disease to diabetes to neurological disorders.

Assuming that stem cells can truly treat everything, they would still have to prove that menstrual stem cells can be manipulated to the same extent.

LifeCell will introduce special collection kits for women who wish to bank their stem cells. The kit has a silicon cup that can collect up to 30 ml of menstrual blood. "It is like a sanitary napkin or tampon, and can last up to eight hours," explained Abhaya.

Kind of messy isn't it?

If you'd like to know what questions to ask and what kind of assurances you're getting for your money, you might want to check out this posting that we reviewed a while ago.

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Cryo-Cell International Inc. changes from Vials to BAGS conforming to US AABB Cord Blood Stem Cell Banking Standards

I read recently that one of the oldest and largest banks in the US has recently announced their financial results and described at the same time that they had made a fundamental change in the way they bank cord blood stem cell units, resulting in a 5X increase in their price of cord blood banking.

The recent Cryo-Cell International Inc. (OTC Symbol: CCEL or CCCEC) First quarter results for 2006 showed that although revenues were up by 12% from 2005, cost of sales was up by 7% and marketing, general and administrative expenses were up by 5%, all compared to the first quarter 2005.

The increase in cost of sales was attributed to:

1) Increased cost in lab supplies
2) Sales Promotions and Cord Blood Collection Reimbursements
3) Service Enhancements

The 1st point involving lab supplies increase was due to "the Company's April 2005 implementation of a new processing methodology in accordance with newly established standards of the AABB (formerly known as American Association of Blood Banks). The new process utilizes closed-system bags in place of vial storage".

With regards to how they are going to maintain their on-going financial strength, Cryo-Cell International Inc has raised their prices of cord blood stem cell banking.

Cryo-Cell Price Change to reflect change in storage system:

Vials Storage- USD 315 (initial), USD 50 (on-going). ie. RM 1170 (initial) and RM 190 (yearly)

TO

BAG Storage - USD 1,595 (initial), USD 125 (on-going). ie. RM 6,061 (initial) and RM 475 (yearly)

This means that Cryo-Cell's cord blood stem cell banking program has increased by 5X and yearly by 2.5X.

What this price increase does show is that lab consumables when using a bag system is more expensive than vials. However, due to the new safety regulations on cord blood banking, cryo-bags are now the standard. It may be merely a matter of time before most stem cell banks using vials change to the bag system in order to conform to international standards.

Analysis and Reasoning:

Coming from the angle of usage, many proponents of vials argue that by storing in several vials, a patient may be able to use each vial for a single treatment. However, this is misleading especially since:

a) ex-vivo expansion is not readily available and expensive
b) not every bag of cord blood collected contains sufficient cells for splitting into multiple vials
c) thus far, transplanters have used whole bags of cord blood and now propose using double cords to constitute sufficient numbers.

However, from the angle of safety:

a) bags use closed system processing (cells not exposed to air during transfer stages)
b) In handling of the bag, cells won't be spilt (unlike vials, potential spillage if mishandled)
c) Labelling safety- the unit is kept as one
d) Better risk management for transplant (no popping of cap or transfer needed when it comes to an IV line)

I also read separately that Cryo-Cell made a licensing agreement with an Indian company called Lifecell. Lifecell pays licensing fees to Cryo-cell Intl. Inc. for its set up and operations- with licensing fees contributing approximately 10% of Cryo-cell's topline revenue. It is unclear to me from their website whether Lifecell in India uses bags or vials for cord blood stem cell banking and if they currently use vials, when or if they will also make the change to bag systems.

But, looking at the prices that Lifecell charges since its launch in November 2004:

Enrolment & Processing = 27,000 Rupees (USD 599 ; RM 2,183)
Yearly storage = 2,900 Rupees (USD 64 ; RM 234)

And taking into account that Lifecell started in late 2004, perhaps they may not be using the bag system.

I wonder if our competitor in Malaysia (check out their amusing blog here) will continue trying to promote the benefit of vials given the clear (yet expensive) message that Cryo-Cell sends by changing all of their processes and systems to accomodate the benefits of storage in bags. At StemLife we thought about these issues carefully from our inception, which is why we have always stored in cryo bags and only cryo bags, in spite of the temptation to choose relatively inexpensive vials.

BOTTOM LINE:
Cryo-Cell's announcement confirms the decision of StemLife, Malaysia's first stem cell bank and therapeutics company, to use bags for stem cell storage rather than vials. As Malaysia's first and only company* to have also used stem cells stored in bags, we have first hand knowledge in assisting doctors in the thawing and use of stem cells for therapies when the patients need them. All stem cell units released from our bank have successfully engrafted, a testament that StemLife's cryopreservation procedures are valid.

*StemLife has expanded now to Thailand where Thai StemLife also uses the bag system of stem cell storage. Additionally, we have clients banked from Indonesia and Singapore where they have chosen StemLife's stem cell banking program for their babies' cord blood stem cells.