In our quest to find the best in office, ultrasound guided bone marrow aspiration solution for stem cell injections for our patients, we are continually testing novel approaches and solutions to see how they perform against current standards. In our Round 1 Test of the Marrow Cellutions/Maxx Regen Needle versus a standard multi-port Jamshidi used in a unicortical multi-depth technique, we found that the MC Needle produced a 53% better TNC compared to the multiport Jamshidi used in a unicortical multi-depth technique. The advantage of the MC Needle disappeared however once the marrow aspiration was continued to 55cc and then centrifuged to concentrate the end product.
Chris Centeno, MD, another orthobiologic clinician and researcher completed a similar analysis recently comparing the MC Needle to his technique using a Jamshidi in a multi-cortical technique (ie. 3 cortical aspiration sites) and found that the multi-cortical technique produced a higher TNC that the MC Needle TNC even before concentrating the product from the multi-cortical technique.
In this Round 2 of our testing, we compared the MC Needle against our unicortical, multi-depth technique, harvested from opposite sides of the posterior iliac crest to minimize the scavenger effect we see in Round 1.
Round 2 Method
Our patient was 69 years old. All samples were blinded by code known to the research team but not the lab.
The Marrow Cellution/ Maxx Regen (they are the same needle) was used per company protocol to obtain 8cc of marrow to which 1 cc of heparin was added. The marrow aspiration was not treated further prior to sending a sample to the lab or using for injection.
A standard multiport Jamshidi was used on the opposite iliac crest to obtain 48cc of marrow using 10cc syringes with draws to 7mm. 14-15 mm was drawn at each level followed by a 0.5cm farther penetration of the needle until 48cc of marrow + 7 heparin was obtained for a total of 55cc to process. A sample of this aspirate was sent to the lab.
The aspirate was then filtered and processed thru a Celling Biosciences disposable device and a 14 minute dual spin centrifuge to create the buffy coat. The end product was 8cc. A sample of this bone marrow concentrate was sent to the lab.
SUMMARY OF RESULTS OF ROUND 2
Result 1: The Marrow Cellutions / Maxx Regen Needle yielded a total TNC count of 169 million cells in the 9cc volume in this 69 year old patient.
The unicortical, multi-depth Jamshidi technique yielded a total TNC of 481 million cells in the pre-centrifuge 55 cc volume.
After filtering, centrifuging, and extracting the buffy coat, the total TNC in the 8cc product was 321 million in this 69 year old patient.
DISCUSSION OF ROUND 2 RESULTS
I think our lower than average TNC counts are mostly due to the patient’s age here.
The TNC count was 90% higher in the filtered and centrifuged product which is a significant difference.
The CFU-f/ml results are pending in about 10 days and we will see if they follow the TNC trend.
There are other differences in end product such as red blood cell content and, potentially, growth factor and cytokine content, so we are still not comparing equivalent products. However, at least with the TNC and CFU-f/ml numbers we can compare the MC Needle output with at least one example (Celling Biosciences) of a centrifuged and concentrated solution.
So far the centrifuged TNC count has been higher that the MC Needle TNC count in both of my rounds and in Dr. Centeno’s two rounds. CFU numbers are still pending for all of us I believe….stay tuned!!