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The Stem Cell Market is Projected to Grow Due to Technological Advancements

ISCO, PSTV, VCEL, PLUR

FinancialBuzz.com News Commentary

PR Newswire

NEW YORK, May 31, 2018 /PRNewswire/ --

According to a publication by Research and Markets, the global stem cells market was valued at US$ 5.2 billion in 2016 and is expected to reach US$ 13.7 billion by 2025 expanding at a CAGR of 10.50% from 2017 to 2025. Stem cells therapy is anticipated to transform medical treatments in the coming decades. The report indicates that Drug discovery and development segment will be the fastest growing market throughout the forecast period 2017-2025, due to the factors such as increasing demand for stem cell technology from pharmaceutical giants to reduce the high attrition rate of late stage drug candidates and build innovative cellular models. International Stem Cell Corporation (OTC: ISCO), Cytori Therapeutics, Inc. (NASDAQ: CYTX), Vericel Corporation (NASDAQ: VCEL), Vital Therapies, Inc. (NASDAQ: VTL), Pluristem Therapeutics Inc. (NASDAQ: PSTI)

An example of a recent advancement made using stem cells was reported earlier in 2017. According to Reuters, Scientists have successfully used "reprogrammed" stem cells to restore functioning brain cells in monkeys, raising hopes of helping patients with Parkinson's disease in the future. "This is extremely promising research demonstrating that a safe and highly effective cell therapy for Parkinson's can be produced in the lab," said Tilo Kunath of the MRC Centre for Regenerative Medicine, University of Edinburgh, who was not involved in the research.

International Stem Cell Corp. (OTCQB: ISCO) announced yesterday that, "a paper prepared by the Company has been published in Volume 12, Issue 5 of the Journal of Tissue Engineering and Regenerative Medicine, a prestigious peer-reviewed scientific journal. Due to its scientific relevance, the article has been featured on the cover of the journal's May 2018 issue.

The article, entitled "Supplementation of Specific Carbohydrates Results in Enhanced Deposition of Chondrogenic-Specific Matrix during Mesenchymal Stem Cell Differentiation," discusses a new scalable system developed by ISCO that permits the generation of functional human cartilage tissue derived from the patient's own skin or fat tissue. This process has the capacity to provide greater stability than other tissue that is currently available for the treatment of osteoarthritis, the most common chronic joint condition.

Using this new system, ISCO scientists generated a healthy cartilage‐specific matrix from human mesenchymal stem cells that had significantly higher viability and cartilage specific properties, including: proteoglycan, aggrecan, hyaluronic acid, and collagen II deposition and glycosaminoglycan production. This new cartilage-specific matrix was built in 3D format and is ready for further therapeutic development.

"While the treatment of Parkinson's disease has always been at the forefront of our research efforts, we are also pursuing various other therapeutic indications. In one of those other areas,our R&D Team has significantly improved the process by which we can use the patient's own mesenchymal stem cells to potentially treat osteoarthritis," commented Russell Kern, PhD, ISCO's Executive Vice President and Chief Scientific Officer. "We are also thrilled to announce that this research gives us a basis to launch program to develop supplements designed to potentially reduce joint pain and improve overall mobility," he continued.

According to the Centers for Disease Control and Prevention (CDC), osteoarthritis is the most common form of degenerative joint disease and affects as many as 27 million Americans.

Characterized by progressive erosion of the articular cartilage, osteoarthritis can damage any joint in the body-most commonly in the hands, knees, hips, and spine. The erosion of articular cartilage leads to joint pain, stiffness, and impaired mobility.

Healthy cartilage permits bones to glide over one another. It also absorbs energy from the initial burst of physical movement. In osteoarthritis, the surface layer of cartilage collapses and wears away. This allows bones under the cartilage to rub against one another, causing pain, swelling, and loss of motion of the joint."

Cytori Therapeutics, Inc. (NASDAQ: CYTX) is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. On March 28, 2018, the company announced that full enrollment has been reached in the ADRESU investigator-initiated clinical trial of Cytori Cell Therapy™ for men with stress urinary incontinence as a complication of prostate intervention. A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial. ADRESU is an investigator-initiated, multicenter, 45 patient, open-label, single arm clinical trial of Cytori's ECCI-50 cellular therapeutic, comprised of Celution®-prepared autologous Adipose Derived Regenerative Cells (ADRCs) and Adipose Cells.

Vericel Corporation (NASDAQ: VCEL) is a leader in advanced cell therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. Earlier this month, the company reported financial results and business highlights for the first quarter ended March 31, 2018. Total net revenues of $18.0 million compared to $9.4 million in the first quarter of 2017; first quarter 2017 revenues included a $2.8 million revenue reserve for Carticel® and MACI® related to a contractual dispute between one of the Company's pharmacy providers and a third-party payer. The company achieved record first quarter revenues and the fourth straight quarter of 30% or greater revenue growth versus the same quarter of the prior year.

Vital Therapies, Inc. (NASDAQ: VTL) is a biotherapeutic company developing a cell-based therapy targeting the treatment of acute forms of liver failure. The Company's ELAD System is an extracorporeal human allogeneic cellular liver therapy currently in phase 3 clinical trials. On March 22, 2018, the company announced that the VTL-308 phase 3 trial has reached its enrollment target of 150 subjects. VTL-308 is the Company's phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with severe alcoholic hepatitis (sAH). The trial, which enrolled its first subject in May of 2016, was designed based on learnings from pre-specified and post-hoc analyses of the Company's VTI-208 clinical trial. Subjects in VTL-308 were randomized 1:1 to either ELAD plus standard-of-care, or standard-of-care alone. The primary endpoint is overall survival through at least 91 days assessed using the Kaplan Meier statistical method.

Pluristem Therapeutics Inc. (NASDAQ: PSTI) is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering latestage trials in several indications. On April 30, 2018, the company announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its PLX-R18 cell therapy in the treatment of acute radiation syndrome (ARS). The U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) sponsored and completed a successful Phase II-equivalent study of PLX-R18 in the treatment of ARS via the FDA's animal rule pathway. PLX-R18 is Pluristem's second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure.

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