scholarly journals The “Marrowminer”, A Novel, Minimally Invasive Device for the Harvest of Bone Marrow: Results From the Marvelous Trial Demonstrate Safety, Efficacy and Improved Stem Cell Yields Compared to Standard Marrow Harvest Method

2009 ◽  
Vol 15 (2) ◽  
pp. 18
Author(s):  
D. Kraft ◽  
M. Crocker ◽  
O. Ramella ◽  
V. Ghazarossian ◽  
A. Carrasco Yalan
Author(s):  
Gramegna Mario ◽  
Ponticelli Francesco ◽  
Baldetti Luca ◽  
Gallone Guglielmo ◽  
Regazzoli Damiano ◽  
...  

2008 ◽  
Vol 2 (2) ◽  
Author(s):  
Christopher P. Erdman ◽  
Stephen M. Goldman ◽  
Patrick J. Lynn ◽  
Matthew C. Ward

Blood sugar management is particularly critical in the neonatal intensive care unit where the incidence of hypoglycemia is high and patients run the risk of brain damage. The staff at most hospitals obtain glucose levels in infants by drawing blood from the heel, which is a cause for recurrent pain. Some infants undergo this procedure every 1–3hours for up to a few months. Our goal is to design a minimally invasive device that allows for real-time glucose monitoring in very low birth weight infants in the neonatal intensive care unit (NICU). This glucose monitor will reduce the amount of pain and physiological stress on the infants, decrease the risk of hypoglycemia in neonates and reduce the workload on hospital staff. There is currently much room for emerging technologies in this market as it trends towards less pain and faster responses. The device should only slightly hinder the infant’s motion, be as painless as possible, and all materials used in contact with the body need to be biologically inert and cause no irritation or allergic reaction. The device will utilize a microneedle array to extract interstitial fluid and draw it through a hydrophilic polyurethane membrane and into a polarimetry chamber. Circularly polarized light will be passed through the chamber and the differential absorbance of left and right polarized light will be used to calculate the glucose concentration. A literature and patent review showed that each separate portion could be used in an effective device for minimally invasive, continuous glucose monitoring.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4130-4130
Author(s):  
Daniel L. Kraft ◽  
Vartan Ghazarossian ◽  
Mike Crocker ◽  
Sergio Najar ◽  
Antonio A. Carrasco-Yalðn

Abstract INTRODUCTION: Bone marrow (BM) contains a rich supply of adult stem and progenitor cells, including hematopoieitic and mesenchymal stem cells which are used in Bone Marrow Transplantation (BMT) and an increasing array of regenerative therapies. Traditional marrow harvest methods utilize percutaneous large bore needle aspiration, result in marrow highly diluted by peripheral blood, and are crude, tedious, labor intensive and expensive, usually requiring general anesthesia, and >100 serial small volume aspirates to obtain adequate cell numbers for BMT. BM is showing increasing long-term advantages over mobilized PBSC for many alloegeneic BMTs, in terms of less cGVHD and in some cases improved survival. Improved BM harvest methods are needed. A novel device, the “MarrowMiner” (MM), was developed for the minimally invasive harvest of BM to enable the rapid, convenient, outpatient harvest of large quantities of BM under local anesthesia for use in allogeneic and autologous BMT and cell therapies utilizing autologous marrow derived cells. The MarrowMiner utilizes a single marrow entry site into the anterior or posterior iliac, through which the flexible, powered, guidable FlexShaft catheter can access the majority of the marrow space and aspirate rich marrow. Extensive testing in human cadavers and porcine models demonstrated a 10X increase in stem cells activity/ml (by CFU) compared to that of traditional needle harvests. The MM recently received both FDA and CE Mark regulatory approved, and ‘First In Human’ trials were successfully completed under local anesthesia, demonstrating safety, efficacy and higher stem cell yields compared to traditional methods. METHODS: In an ongoing prospective study, 10 patients undergoing autologous marrow derived therapy for use in regenerative medicine, had marrow harvested from their anterior or posterior ileac by the MM under local anesthesia on one hip, with direct comparison to standard needle serial marrow aspirates on the patients opposite hip (up to 350 ml per side). Cell viability, counts, CD34+, T cell, and MSC populations were assessed by flow cytometry. RESULTS: The MM successfully harvested marrow from a single entry sites and 2–3 paths under local anesthesia, without complications. Compared to standard harvest in the same patients, MM harvests had significantly number of Total Nucleated Cells ml compared to marrow harvested from the same patient by standard needle ( mean 1.98 fold greater TNC (range 0.87–3.36, p<.05). Viability was equivalent at (>99). In addition to higher TNC/ml, significantly higher levels (mean 3.56 fold) of Aldeflour/ALDH+ cells/ml, CD34+, and phenotypic MSC (CD45−,34−,90+,105+) and endothelial progenitor cells were obtained, as measured by flow cytometry. Mean CD3+ T-cell counts per ml were lower with MM harvests. CONCLUSIONS: The novel FDA approved MarrowMiner system demonstrated safety and efficacy in clinical use, harvesting more stem cells per unit volume in a single entry compared to standard harvest methods. These results suggests the MM may enable improved clinical stem cell harvests in a more rapid and minimally invasive manner in the outpatient setting, while harvesting a richer marrow product with less peripheral blood contamination. Such a system, facilitating convenient, on demand stem cell collection may have significant application for BMT and other marrow based cellular therapies.


Author(s):  
Tariq H. Khan

Rheo Probe is a minimally invasive device, implanted in the brain matter for patients in a coma following brain haemorrage or traumatic brain injuries to measure cerebral blood flow, intracranial pressure, temperature and oxygenation parameters. Nearinfrared sensors assess levels of tissue oxygenation as well as cerebral blood flow by measuring oxygenated and deoxygenated hemoglobin based on spectrometry.


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