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Commission File No. Totipo tentrx. Over the past decade, the use of regenerative medicine methodologies, and specifically bone marrow derived progenitor cell therapy has been tested in more than 35 Phase I and Phase II clinical studies demonstrating overall safety and measurable clinical benefit months post treatment as evaluated by improvement of the Left Ventricular Ejection Fraction LVEF and changes in infarct size post AMI. Recent meta-analysis on the subject highlighted several important parameters that include timing of the stem cell therapy post AMI, the cell dose, and the baseline of the LVEF on enrollment.

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No reduction in scar size was observed with a heart mass of Commission File No.

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Conducting such a point-of-care treatment on this subject was straightforward and very exciting for me as a practicing interventionalist. The cardiac chambers appeared normal with no s of pericardial effusion.

More than subjects have been investigated in these studies, and there is a clear evidence for safety of this therapy, however, its efficacy is still debated because of inconsistent reported in the literature. Figure 5: Schematic representation of the AMIRST treatment, achieving the optimal time for any bedside escorf in the heart catheterization procedure. Figure 2 represents an overview of the approach.

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These potent progenitor cells can be isolated from different sources within the adult human body. Additionally, a clinical team using the AMIRST approach is able to verify that the harvesting and processing steps have yielded the desired minimum cellular dose by employing our rapid bedside diagnostics. Our procedure utilizes a proprietary controlled process and device which minimizes and measures these critical variables.

Over the past decade, the use of regenerative medicine methodologies, and specifically bone marrow derived progenitor cell therapy has been tested in more than 35 Phase I and Phase II clinical studies demonstrating overall safety and measurable clinical benefit months post treatment as evaluated by improvement of the Left Ventricular Ejection Fraction LVEF and changes in infarct size post AMI.

The patient remained hospitalized for telemetry an additional 24 hours post cell transplant, and released with standard cardiac therapeutics as listed in Table 3. The methodology employs a heparin-free bone marrow aspiration along with a user independent automated processing system to extract BMCePC rapidly in a point-of-care controlled environment.

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Despite obtaining excellent in lab animal studies, human clinical have remained underwhelming in the prior studies. Following the aspiration, the bone marrow was processed employing our proprietary point-of-care technology platform to produce bone marrow concentrate enriched in progenitor cells BMCePC. Following Myocardial Infarction MIendogenous mechanisms strive to prevent further cardiac damage and remodeling. Overall, the study demonstrated safety of our bone marrow aspiration, processing and infusion methodology in an acute low LVEF infarct patient esckrt PTCA.

Despite ificant advances in medical therapy and revascularization strategies, the prognosis of certain patients with acute myocardial infarction AMI remains dismal without the introduction of early biological repair intervention. The secreted Indepenndent increase the responsiveness of CXCR4-positive bone marrow progenitor cells, however, due to limited mobilization the effective repair does not take place.

Harvesting, enriching and infusing potential progenitor cells is our approach for cardiac repair and regeneration. The safety and positive clinical benefits demonstrated in this single patient case study are most encouraging as we begin the double-blinded AMIRST study which will certainly provide statistically ficant insights. Along with reperfusion, adjuvant progenitor cell therapy has been shown to be potentially efficacious in the repair and regeneration of damaged heart tissue.

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This is likely another plausible reason for inconsistent in clinical trials thus far. An estimated Anticoagulants, a chemical added to bone marrow aspirate to prevent the formation of microthrombae, plays a crucial role in the overall efficacy of regenerative cell therapy. The cardiac output volumetrics also showed an insependent from 2.

The patient was advised that he met the inclusion criteria for the AMIRST clinical trial program using his own autologous bone marrow stem cells. The month follow-up could not be completed due to nonavailability of patient, but all other follow-up points were completed. The clinical trial is registered with clinicaltrials. Moreover, heparins are associated with high rates of peri-procedural bleeding, which may be related to rncho inability to bind to clot-bound thrombin.

Since completing the treatment of this patient, we have further optimized the method for harvesting the stem cells, processing the stem cells, and testing the quality and quantity of the cells. No major adverse cardiac events MACE including rehospitalisation were reported, demonstrating the safety of this adjuvant treatment. Moreover, the manual ficollpaque method is highly user-dependent but should have been addressed in the automated approach used in the TIME study.

Simply assuming specific cell types demonstrated in a lab model are ready for clinical trial, and expectations that such biology alone is predictable and reproducible equates to the pharmaceutical industry completely skipping the quality demands and parameters of statistical process control in manufacturing. Another major factor that influences the potency of bone marrow derived cellular product is the processing technology employed to harvest the desired cellular fraction s.

Prime Clerk Thank you for visiting Prime Clerk. Most studies analyze the cellular viability, and fewer analyze the cellular potency of the cells pre- and post-traversing the catheter. It is understood that the addition of any chemical entity in crodova presence of proteins or cells may have an effect on their structure or function or both.

Addressing this we have developed a rapid — 60 to 90 minute process and integrated system which is carried out in the heart catheter lab, using a combination product U. Therefore, an absolute quantitative equivalency measurement of LVEF between the pre-treatment and 3-months post treatment should be evaluated cautiously.

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As the cell therapy evolves from pre-clinical through clinical phases, development of reproducible point-ofcare integrated systems become absolutely necessary. The next independenr will be to complete a randomized double blinded placebo controlled multi-centre Phase 1B trial in 30 patients. Cardiac imaging was performed at each follow-up. We are enthusiastically looking forward to begin the randomized placebo control double blinded Phase 1B study in the coming few months where the latest improvements will be incorporated.

It has been suggested that bone marrow derived autologous cellular products prevent adverse cardiac remodelling by a synergy of mechanisms as described in figure 4.

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Some scientists and clinicians suggest that coddova processing techniques utilized in bone-marrow processing, at least to some extent, are a plausible reason secort conflicting and unpredictable in clinical trials. The final critical variable controlled in our treatment method is the utilization of an inherently cell friendly and endothelium safe intracoronary catheter deed to measure and control the impact of pressure, shear, and surface chemistry within the delivery lumen on the therapeutic cells.

As a preliminary safety study prior to full subject enrollement, the patient was followed up for 24 months, and evaluated with standard diagnostic metrics. Our point-ofcare technology can accomplish the complete procedure, from bone marrow harvest to infusion, in 60 minutes as shown in figure 5, thus minimizing any impact of time and environmental effects on the therapeutic cells.

Recent meta-analysis on the subject highlighted several important parameters that include timing of the stem cell therapy post AMI, the cell dose, and the baseline of the LVEF on enrollment. The cellular product contained a total of 3.

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