It is a fantasy to believe that researchers and company representatives try to answer the important questions in medicine only with what is best for a population of patients. Those who work in healthcare are human beings and just as prone as any other humans to acting in their own interest; responding to economic incentives, and stumbling into blatant fraud. Anybody who has knocked around in the world and read works from Dante, Juvenal, Balzac or Dickens knows that this is how human beings behave. (see J R Soc Med. 2006 Jun; 99(6): 292–297.) The email being circulated by Terumo / Harvest is just such an example of this. Their claims have been paraphrased and addressed individually as follows:
Harvest Claim: Marrow Cellution is cleared under a urology code for a tissue biopsy and is not FDA cleared for use in aspirating a tissue for point of care use, so anyone using this device lacks legal protection.
The Marrow Cellution needle has the same clearance as the needle included in the Harvest kit. Neither one carries any different “legal protection” as they have the same FDA clearance. This claim is misleading at best.
Harvest Claim: All 3 Marrow Cellution white papers are done in-house by early investors or owners, like Dr. Purita.
Dr. Purita is neither an investor or owner. This statement is false and fraudulent.
Harvest Claim: None are peer-reviewed or published.
This statement is true; however the work by Dr. Scarpone is being submitted for publication; this is a process that takes some time and the product is relatively new.
Harvest Claim: There are serious problems with our MSC (CFU-f) cell count data.
Our CFU-f data has been performed by two independent labs and each clinician submitting samples had no financial conflict of interest except that complimentary needles are often provided for a couple of early cases for the clinician to decide if they want to incorporate the product into their practice. The CFU-f counts in the Harrell paper were performed by two independent labs; one of whom Harvest engaged and paid!
Harvest Claim: If you look at the Purita paper most patients produce 1,000-1,500, which is inferior to most concentrate systems.
This statement is false. See paper done by HSS* and published in Journal of Orthopedic Trauma; Average CFU-f count per mL for two different series of 20 using the Harvest BMAC system was 1,014 and 1,270, respectively.
*Hegde V. et al. Journal of Orthopedic Trauma 2014; vol 28; issue 10; p 591-598
Harvest Claim: The second Harrell paper (another owner/investor) was done in-house and without Harvest's input/oversight so who knows how they get low MSC counts from the Harvest BMAC system.
This statement is false and fraudulent. Dr. Harrell is neither an investor or owner. This study was initiated by and designed by Harvest; the clinician that performed the aspirates had performed thousands of Harvest cases, this was the first five he performed with Marrow Cellution. The samples taken were sent to two different labs to ensure accuracy; one of which was engaged and paid by Harvest. Both labs concluded that Marrow Cellution was superior. Harvest personnel were present for all of the cases. See Harvest ppt. presentation that summarizes the results of the study. Note that the first thing a Hematologist does to make sure they have a good aspirate is to do a smear and ensure that small pieces of the sponge marrow are present (i.e. spicule); no spicules means that the aspirate is all blood and not marrow.
Harvest Claim: Harvest routinely produces MSC counts in the 2,200-3,200 range.
We are not aware of any papers that are performed in a clinical setting that show Harvest having more than 1,270 CFU-f per mL (see paper referenced above). When Harvest is used with purchased marrow from a commercial source (young donors and samples screened for a certain cellular content before shipment) the counts have been higher. But this data is not indicative of field conditions. All Marrow Cellution data is from true field conditions.
Harvest Claim: The Harrell paper is not valid because they compare in-house patient aspirates with aspirate numbers from a different study and they do not compare to the final concentrate, which is again, just pure fraud.
See Harrell paper, the study design included the same patient, same procedure, with random assignment of alternating hips. Not sure what “in-house aspirates” means. The phrase “numbers from a different study” is incorrect as all samples taken are from the study.
Harvest Claim: Ranfac aspirate is not filtered and has been shown to contain spongy bone chips and bone spicules. This is not a problem in bone graft work for spinal fusion, for example, but do not inject fluid with these bony bits into a joint space.
A 150 micron cartridge filter is available to filter the marrow if a clinician so desires. We have performed thousands of procedures with and without a filter - it is a clinician preference.