The Regenexx Procedure Newsletter
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IV Cell Therapy
Case Study of the Month
FSA Reimbursement
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  If you or someone you know may be a candidate for a stem cell therapy procedure for joint, ligament, cartilage or bone please feel free to forward this and have them click on our  
 
 
 
Issue: # 4 January 2009
In this issue of the Regenexx Procedure News we hope you find interesting and pertinent material about chronic musculoskeletal problems.  As always, you can find more information at our website www.regenexx.com.  In addition, for more information on stem cell research, check out the clinic blogs at:
 
Stem Cell Research Update
Pulmonary First Pass Effect:  So Much for IV Therapy using Adult Stem Cells adult cells  
 
As you may know, many outside the country organizations use an IV injection route to deliver stem cells.  While this has made some sense at face value (stem cells are supposed to be able to home to an injured area), most studies have confirmed that very few of these IV delivered stem cells end up in the injured area (as compared to direct injection of cells into the injured area).  Fischer et al in a recently published paper just found out why, there is a "Pulmonary First Pass Effect" similar to the Hepatic First Pass seen in drug delivery.  In this case the cells end up getting sequestered by the lungs.  This again confirms that while placing cells IV may be easy, it is not a reasonable delivery method for stem cells at this time.  Direct delivery into the target tissues would seem the only safe bet.
 
Bone Marrow Nucleated Cell Concentrate (BMAC): Is it Concentrated Enough?
 
BMAC has become popular of late.  In this procedure, a physician takes a bone marrow aspirate, places it in a specially designed centrifuge and pulls out a concentrate of bone marrow nucleated cells.  This has been billed as a stem cell concentrate, but the stem cells that are concentrated in reasonable numbers tend to be CD34+ heme progenitors (stem cells that make new blood) and not MSC's (Mesenchymal Stem Cells).  Since MSC's are the MVP of the adult stem cell mix available in a bone marrow concentrate, their concentration is very important to the success of such a treatment.  
 
A recent study on bedside bone marrow concentrate machines for MSC's (BMAC) determined what concentrations were possible from a commercially available centrifuge unit.  Using this study to calculate MSC numbers, a 60 ml bone marrow draw would produce 70,000-90,000 MSC's.  The Regenexx procedure yields after culture expansion are in the 5 million-100 million range.  Based on this data, the Regenexx procedure produces approximately 100-1,000 times more cells than you can obtain with BMAC bedside systems.  Based on this and other data, our best estimate is that the average micro fracture procedure would release 5-10 ml of un-concentrated marrow, so about 500-1,000 MSC's into the defect site. 

Our own dosing data and the copious animal research would suggest that for appropriate cartilage, tendon, ligament, muscle repair the necessary MSC dose is in the 1M to 30M range.  Obtaining that amount of MSC's from a BMAC system would require unacceptably high volumes of whole marrow from the patient.

Click here for a video of Dr. Centeno discussing the future of stem cell therapy.

Case Study of the Month
Harold photoThe Regenexx Procedure Helps Patient's Severe Ankle Pain
 
Harold is a 61 year old WM with a long history of chronic ankle pain.  He was diagnosed with instability and osteoarthritis and went on to triple arthrodesis in 2005.  One of the arthrodesis screws hit an important artery and he developed avascular necrosis with collapse of the talar dome. 
 
As you can see from his x-ray below, Harold had what we call in the venacular, "Hardware Store Ankle".  Harold was in chronic pain an unable to walk long distances or play golf by 2007 when he was first evaluated.  He has received two Regenexx procedure rounds, with autologous, culture expanded, mesenchymal stem cells being injected into his talar dome and lateral ankle ligament regions (under MRI planned fluoroscopy).  His pain has decreased and his function has dramatically increased.  He now enjoys playing golf again. Click here for a video of another ankle case where the Regenexx procedure healed severe damage of the lateral ankle ligaments.
 Harold ankle
Time is Running out for 2008 FSA Reimbursement.
You have until March 15, 2009 to use up the remainder of your 2008 FSA account in most cases.  IRS regulations allow an additional 2.5 months to use of previous year's FSA funds. Below is the IRS regulation as it pertains to FSA "rollover" that we have found interesting.  The Regenexx procedure is considered a medical procedure and therefore is covered under the flexible spending account regulations of the IRS.  Please consult a tax professional regarding eligibility and use of FSA accounts.  Also check with your employer to see if your plan allows this grace period.
 
This is an excerpt from the IRS web page linked above on page 17;
 
Balance in an FSA
 
Flexible spending accounts are "use-it-or-lose-it" plans.  This means that amounts in the account at the end of the plan year cannot be carried over to the next year.  However, the plan can provide for a grace period of up to 2 1/2 months after the end of the plan year.  If there is a grace period, any qualified medical expenses incurred in that period can be paid from any amounts left in the account at the end of the previous year.  Your employer is not permitted to refund any part of the balance to you.
 
 
IF you have any questions regarding FSA reimbursement for the Regenexx procedure please feel free to contact our office at info@regenexx.com
Regenerative Sciences is a company out of Broomfield Colorado that treats patients with joint, tendon and bone injuries using the patients own adult stem cells.  Our breakthrough procedure has helped hundreds of patients avoid invasive surgery and get back on track with the healing process.  If you or someone you know would like to find out more about our procedure, please forward this newsletter or direct them to our website www.regenexx.com.
 
Sincerely,
 

The Regenexx Team
Regenexx