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Compositions and methods of vascular injury repair

a technology of hematopoietic stem cells and compositions, applied in the direction of drug compositions, extracellular fluid disorders, catheters, etc., can solve the problems of permanent cardiac dysfunction, increased lifetime risk of experiencing adverse cardiac events, and further demise of cardiac function, so as to achieve the sterility of the chemotactic hematopoietic cell produ

Active Publication Date: 2012-03-22
CALADRIUS BIOSCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because myocardial cells have virtually no ability to regenerate, myocardial infarction leads to permanent cardiac dysfunction due to contractile-muscle cell loss and replacement with nonfunctioning fibrotic scarring.
Moreover, compensatory hypertrophy of viable cardiac muscle leads to microvascular insufficiency that results in further demise in cardiac function by causing myocardial muscle hibernation and apoptosis of hypertrophied myocytes in the peri-infarct zone.
Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize ventricular wall stresses, a significant percentage of patients experience ventricular remodeling, permanent cardiac dysfunction, and consequently remain at an increased lifetime risk of experiencing adverse cardiac events, including death.
In the setting of a brief (i.e., lasting three minutes to five minutes) coronary artery occlusion, energy metabolism is impaired, leading to demonstrable cardiac muscle dysfunction that can persist for up to 48 hours despite immediate reperfusion.
After successful revascularization, significant recovery from stunning occurs within three to four days, although complete recovery may take much longer.
To date, no ideal therapy exists for preventing the long term adverse consequences of vascular insufficiency, particularly the significant vascular insufficiency that results in a myocardial infarction.
While large vessel revascularization (meaning the successful placement of a stent) seems promising, studies to date have shown such applications to be insufficient in addressing increased demands posed by compensatory myocardial hypertrophy.
To date, however, no ideal therapy exists for preventing the long-term adverse consequences of vascular insufficiency, for example vascular insufficiency that produces myocardial infarction.

Method used

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  • Compositions and methods of vascular injury repair
  • Compositions and methods of vascular injury repair
  • Compositions and methods of vascular injury repair

Examples

Experimental program
Comparison scheme
Effect test

example 1

Selection of Eligible Subjects

[0164]Subjects / patients presenting with symptoms and clinical findings suggestive of a myocardial infarction will receive emergency diagnostic and clinical management according to institutional guidelines. If a transmural (meaning through the wall) myocardial infarction is confirmed, the time of first symptoms and the time of successful stent placement will be recorded. Revascularized subjects will receive appropriate medical management to reduce ventricular wall stresses according to institutional guidelines. The term “revascularized” as used in this embodiment, refers to the successful placement of a stent.

[0165]All types of stents, including drug-eluting stents (e.g., paclitaxel or sirolimus) are acceptable for use in the revascularization of the infarct related artery (“IRA”). Previous studies employing balloon catheters to infuse cell products have reported no limits for reference vessel diameter for the placement of the stent. Since this study is ...

example 2

Cardiac Catheterization

[0177]Sterile Preparation and Draping

[0178]The subject will be brought into the Cardiac Catheterization Laboratory after the investigator has obtained an informed consent. The subject will receive a sterile preparation and draping in the Cardiac Catheterization Laboratory.

[0179]Cardiac Catheterization

[0180]Vascular access will be obtained by standard technique using right or left groin. A sheath will be placed in the femoral artery or the right or left brachial artery. Coronary arteriographic examination will be performed by obtaining standard views of both right and left coronary arteries. Multiple views will be obtained to identify the previously stented infarct related artery. All subjects will receive standard medications during the catheterization procedure in accordance with routine practice.

example 3

Acquisition Process For Acquiring Chemotactic Hematopoietic Stem Cell Product That Can Then Be Enriched For CD34+ Cells

[0181]While it is contemplated that any acquisition process appropriate for acquiring the chemotactic hematopoietic stem cell product comprising potent CD34+ cells is within the scope of the present invention, the following example illustrates one such process referred to herein as a mini-bone marrow harvest technique.

[0182]Preparation of Harvesting Syringes

[0183]According to one embodiment, prior to the bone marrow harvest, forty 10 cc syringes optionally loaded with about 2-ml of a preservative free heparinized saline solution (about 100 units / ml to about 125 units / ml, APP Cat. No. 42592B or equivalent) will be prepared under sterile conditions. According to one embodiment, heparin will be injected via a sterile port into each of two 100-ml bags of sterile 0.9% normal saline solution (“Normal Saline”, Hospira Cat. No. 7983-09 or equivalent) following removal of 10...

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Abstract

The present invention relates to pharmaceutical compositions comprising a chemotactic hematopoietic stem cell product comprising an enriched population of CD34+ cells containing a subpopulation of CD34+ / CXCR-4+ cells having CXCR-4-mediated chemotactic activity, methods of preparing these compositions and use of these compositions to treat or repair vascular injury, including infarcted myocardium.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. application Ser. No. 12 / 401,291, filed Mar. 10, 2009, which is a division of U.S. application Ser. No. 11 / 552,396, filed Oct. 24, 2006, now U.S. Pat. No. 7,794,705, claiming priority to U.S. Provisional Application Ser. No. 60 / 734,151, filed Nov. 7, 2005. The entire contents of each of these applications are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to compositions comprising a chemotactic hematopoietic stem cell product and methods of use thereof in repairing injury caused by vascular insufficiency, including infarcted myocardium, as well as other vascular conditions similar to or related to vascular insufficiency.BACKGROUND OF THE INVENTION[0003]Acute myocardial infarction remains common with a reported annual incidence of 1.1 million cases in the United States alone (Antman, E. M., Braunwald, E., Acute myocardial infarction, in Principle...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M25/10A61M25/14A61P9/10A61K35/12A61P9/00A61F2/958A61K35/28
CPCC12N5/0647A61K35/28A61K35/14A61P7/02A61P7/10A61P9/00A61P9/06A61P9/10
Inventor PECORA, ANDREW L.PRETI, ROBERT A.
Owner CALADRIUS BIOSCI
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