BioLeonhardt has developed a programmable implantable stem cell infusion pump and electrical stimulator combination for treating advanced heart failure.

The stem cell pump is implanted in the patient’s abdomen and has a silicone septum which allows re-loading via a micro needle syringe of stem cells, genes, growth factors and nutrient hydrogels. The pump is attached to a combination coaxial reinforced infusion catheter and electrical conduction lead which has its tip anchored into the patient’s damaged heart tissue.

BioLeonhardt is teamed with Core Manufacturing, an Alfred Mann Companies spin out, that is staffed with members that have a long history developing related devices including the pacesetter systems heart pacer sold to Siemens then St. Jude Medical, the MiniMed implantable insulin pump sold to Medtronic and the Advanced Bionics implantable pain relief pumps sold to Boston Scientific.

BioLeonhardt intends to bring to market a therapy for heart failure utilizing their own stem cell pump and to offer the pump as well to other researchers with different therapies.

BioLeonhardt’s own proposed method to treating heart failure:

1. Pre-Treat Scar – Micro-RNAs, nutrient hydrogel, growth factors, electrical stimulation, GCSF, endothelial progenitor cells and adipose derived cells.

2. Treat Scar – Muscle derived cardiac progenitor cells in center of scar, cardiac stem cells or iPS cells at rim edge of scar, temporary implantable circulatory assist pump to allow heart to rest.

3. Post Implantation Scar Maintenance – Repeat injections/infusions + electrical stimulation.

BioLeonhardt Founder, CEO, and lead inventor for the new technology Howard J Leonhardt noted for the past 14 years all stem cell related studies have been limited to one single half hour session of injections or infusions.

"We believe superior results can be obtained by repeat dosing utilizing our programmable implantable pump. BioLeonhardt is designing a controlled study for heart failure with intent to prove this hypothesis," Leonhardt added.

BioLeonhardt has granted an exclusive license for myoblast transplantation with their pump to another Leonhardt founded company Bioheart that has been in clinical trials utilizing selected immature myoblasts to treat heart failure since early 2001.

Over 400 patients have been enrolled in various myoblast trials worldwide. New myoblast related independent trial results will be presented at the conference this week.

Electrical stimulation technology for these studies will be provided by MyoStim Pacers. Electrical stimulation has demonstrated an ability to recruit stem cells to injury sites and differentiate them into useful tissues while improving blood flow and thus healing scars, in both pre-clinical and clinical studies for various applications.

Summary of myoblast transplantation data for heart failure clinical studies:

– 84% of myoblast treated patients have improved in at least one parameter while only 16% have worsened. In comparison 69% of control or placebo patients in the same studies have worsened.

– 33% of MyoCell treated patients have improved by two heart failure classes.

– Bioheart MyoCell treated patients improved 95.7m in exercise capacity over placebo patients that declined 4m. No other cell type has bettered 53m. Allogeneic bone marrow derived cells 10m. CRT Pacers 20m.
– Myoblasts are the only cell composition that has demonstrated an ability to grow new contractile muscle in the center of heart scar tissue.

Pre-clinical studies have confirmed that even superior results can be obtained when the cells are modified to over-express SDF-1 and repeat doses are given over time.