Caladrius Biosciences

Last updated
Caladrius Biosciences
Company type Public
Nasdaq:  CLBS
Russell Microcap Index component
Industry Biopharmaceuticals
Headquarters Basking Ridge, New Jersey [1] ,
United States
Key people
David J. Mazzo (CEO)
Website caladrius.com

Caladrius Biosciences is an American biopharmaceutical company active in the field of stem cell therapy and regenerative medicine, particularly (in 2012) of cardiovascular disease. [2]

Founded in 1980, [3] the company was formerly known as Corniche Group Inc, Phase III Medical Inc, [4] and NeoStem, Inc., it adopted its current name in 2015. [3]

In 2022, Caladrius and Cend Therapeutics merged to form Lisata Therapeutics. [5]

Cardiovascular disease

In 2012 it started a randomized, controlled, double-blind phase 2 clinical trial of AMR-001 (NBS10), an autologous bone marrow-derived cell therapy enriched for CD34+ cells, for marked reduction in left ventricular function following acute myocardial infarction. [6]

The published study results showed no evidence of benefit from pre-specified endpoints, though there appeared to be evidence suggesting possible dose-related benefit in post-hoc analysis from a subset of patients. [7]

Related Research Articles

Stephen E. Epstein is the Head of Translational and Vascular Biology Research at the MedStar Heart and Vascular Institute, MedStar Washington Hospital Center and Clinical Professor of Medicine at the Georgetown University School of Medicine.

In cardiology, ventricular remodeling refers to changes in the size, shape, structure, and function of the heart. This can happen as a result of exercise or after injury to the heart muscle. The injury is typically due to acute myocardial infarction, but may be from a number of causes that result in increased pressure or volume, causing pressure overload or volume overload on the heart. Chronic hypertension, congenital heart disease with intracardiac shunting, and valvular heart disease may also lead to remodeling. After the insult occurs, a series of histopathological and structural changes occur in the left ventricular myocardium that lead to progressive decline in left ventricular performance. Ultimately, ventricular remodeling may result in diminished contractile (systolic) function and reduced stroke volume.

<span class="mw-page-title-main">Cell therapy</span> Therapy in which cellular material is injected into a patient

Cell therapy is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T-cells capable of fighting cancer cells via cell-mediated immunity in the course of immunotherapy, or grafting stem cells to regenerate diseased tissues.

Stem-cell therapy uses stem cells to treat or prevent a disease or condition. As of 2016, the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone marrow transplantation, but the cells can also be derived from umbilical cord blood. Research is underway to develop various sources for stem cells as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease.

Tcelna is an anti-T cell vaccine being studied in multiple sclerosis (MS). As of 2016 it is in phase II trials.

<span class="mw-page-title-main">Levosimendan</span> Pharmaceutical drug

Levosimendan (INN) is a calcium sensitizer used in the management of acutely decompensated congestive heart failure. It is marketed under the trade name Simdax. Overall the drug has a two fold mechanism of action. It leads to greater inotrophy by increasing the calcium sensitivity as it binds to troponin and this results in a greater positive inotrophic force. Secondly, the drug is able to open ATP sensitive potassium channels in vascular smooth muscle cells, and the vascular dilatory effects of the drug lead to a decreased preload and afterload, putting less work on the heart. This drug is in the process of review by the FDA but has not been approved for use in the United States yet.

Erlizumab, also known as rhuMAb, is a recombinant humanized monoclonal antibody that was an experimental immunosuppressive drug. Erlizumab was developed by Genentech under a partnership with Roche to treat heart attack, stroke, and traumatic shock.

In cardiology neocardiogenesis is the homeostatic regeneration, repair and renewal of sections of malfunctioning adult cardiovascular tissue. This includes a combination of cardiomyogenesis and angiogenesis.

<span class="mw-page-title-main">Losmapimod</span> Chemical compound

Losmapimod (GW856553X) is an investigational drug being developed by Fulcrum Therapeutics for the treatment of facioscapulohumeral muscular dystrophy (FSHD); a phase III clinical trial is pending approval. Losmapimod selectively inhibits enzymes p38α/β mitogen-activated protein kinases (MAPKs), which are modulators of DUX4 expression and mediators of inflammation.

<span class="mw-page-title-main">Ifetroban</span> Chemical compound

Ifetroban is a potent and selective thromboxane receptor antagonist. It has been studied in animal models for the treatment of cancer metastasis, myocardial ischemia, hypertension, stroke, thrombosis, cardiomyopathy, and for its effects on platelets. Clinical trials are evaluating the therapeutic safety and efficacy of oral ifetroban capsules for the treatment of cancer metastasis, cardiovascular disease, aspirin exacerbated respiratory disease, systemic sclerosis, and Duchenne muscular dystrophy.

Cardiovascular Cell Therapy Research Network (CCTRN) is a network of physicians, scientists, and support staff dedicated to studying stem cell therapy for treating heart disease. The CCTRN is funded by the National Institutes of Health (NIH) and includes expert researchers with experience in cardiovascular care at seven stem cell centers in the United States. The goals of the Network are to complete research studies that will potentially lead to more effective treatments for patients with cardiovascular disease, and to share knowledge quickly with the healthcare community.

The Cardiac Arrhythmia Suppression Trial (CAST) was a double-blind, randomized, controlled study designed to test the hypothesis that suppression of premature ventricular complexes (PVC) with class I antiarrhythmic agents after a myocardial infarction (MI) would reduce mortality. It was conducted between 1986 and 1989 and included over 1700 patients in 27 centres. The study found that the tested drugs increased mortality instead of lowering it as was expected. The publication of these results in 1991/92, in combination with large follow-up studies for drugs that had not been tested in CAST, led to a paradigm shift in the treatment of MI patients. Class I and III antiarrhythmics are now only used with extreme caution after MI, or they are contraindicated completely. Heart Rhythm Society Distinguished Scientist D. George Wyse was a member of the CAST trial's steering and executive committees.

<span class="mw-page-title-main">Left ventricular thrombus</span> Medical condition

Left ventricular thrombus is a blood clot (thrombus) in the left ventricle of the heart. LVT is a common complication of acute myocardial infarction (AMI). Typically the clot is a mural thrombus, meaning it is on the wall of the ventricle. The primary risk of LVT is the occurrence of cardiac embolism, in which the thrombus detaches from the ventricular wall and travels through the circulation and blocks blood vessels. Blockage can be especially damaging in the heart or brain (stroke).

<span class="mw-page-title-main">Ischemic cardiomyopathy</span> Medical condition

Ischemic cardiomyopathy is a type of cardiomyopathy caused by a narrowing of the coronary arteries which supply blood to the heart. Typically, patients with ischemic cardiomyopathy have a history of acute myocardial infarction, however, it may occur in patients with coronary artery disease, but without a past history of acute myocardial infarction. This cardiomyopathy is one of the leading causes of sudden cardiac death. The adjective ischemic means characteristic of, or accompanied by, ischemia — local anemia due to mechanical obstruction of the blood supply.

Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence, sold under the brand name Strimvelis, is a medication used to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID).

Andrew Louis Pecora is an American hematologist and oncologist involved in research on the use of stem cells and oncolytic viruses to treat diseases, including cancer. He is the CEO of Outcomes Matter Innovations. As of 2020, he is on the Board of Directors Celularity, Inc. (since 2017) and founder and Executive Chairman, COTA, Inc.. Previously, he was chief innovations officer, professor and vice president of cancer services at the John Theurer Cancer Center, part of the Hackensack University Medical Center. He is a professor of medicine and oncology at Georgetown University.

Hans Keirstead is a medical scientist and entrepreneur specializing in stem cell research.

<span class="mw-page-title-main">Sangamo Therapeutics</span> American cell and gene therapy company

Sangamo Therapeutics, Inc. is an American biotechnology company based in Brisbane, California. It applies cell and gene therapy to combat haemophilia and other genetic diseases.

<span class="mw-page-title-main">G1 Therapeutics</span> Pharmaceutical company

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OTL-103 (GSK-2696275) is a gene therapy for Wiskott–Aldrich syndrome, a rare primary immunodeficiency caused by mutations in the gene that codes for Wiskott–Aldrich syndrome protein (WASp). It was developed by Orchard Therapeutics in conjunction with GlaxoSmithKline. It is currently undergoing Phase I/II of clinical trials that are expected to conclude in October 2025.

References

  1. Editorial, Reuters. "CLBS.PH - Caladrius Biosciences Inc Profile | Reuters". www.reuters.comundefined.{{cite web}}: |first1= has generic name (help)
  2. NeoStem CEO Discusses Adult Stem Cell Therapies, May 14, 2012. Bloomberg Television. 3m35s video. Accessed September 2015.
  3. 1 2 "Caladrius Biosciences - Consensus Indicates Potential 316.7% Upside - DirectorsTalk Interviews" . Retrieved 2021-05-03.
  4. EDGAR Search Results – Neostem, EDGAR
  5. Caladrius Biosciences and Cend Therapeutics Announce Closing of Merger and the Emergence of Lisata Therapeutics, September 15, 2022
  6. NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction (PreSERVE-AMI)
  7. Arshad A. Quyyumi (2017). "PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Administration of Autologous CD34+ Cells in Patients With Left Ventricular Dysfunction Post STEMI". Circulation Research. 120 (2): 324–331. doi:10.1161/CIRCRESAHA.115.308165. PMC   5903285 . PMID   27821724.