Spinal Stem Cell Injections Help Reverse Paralysis [Medicine]

A new medical intervention has allowed doctors to inject neural stem cells into the spines of paralyzed patients, successfully helping them recover feeling in previously unresponsive parts of their bodies.

New Scientist reports that a small trial involving three partially paralyzed patients saw injections of 20 million neural stem cells administered directly into their spinal cords. The stem cells were harvested from donated fetal brain tissue, and the patients received immunosuppressive drugs to minimize the risks of rejection.

Before treatment, all of the patients could feel nothing below their nipples. Six months on, two of them can now feel touch and heat as far down as their belly button. While that may not sound impressive, it's a massive leap forward in the treatment of paralysis. Stephen Huhn, one of the researchers, told New Scientist:

"The fact we've seen responses to light touch, heat and electrical impulses so far down in two of the patients is very unexpected. They're really close to normal in those areas now in their sensitivity."

These three patients are the first of 12 to undergo the therapy, and the positive results will see Huhn and his colleagues push on with the tests. The results were presented yesterday in London at the annual meeting of the International Spinal Cord Society.

While it's not clear exactly how the stem cells improve sensitivity, the researchers suggest that they may be helping restore myelin insulation of damaged nerves, or perhaps causing existing nerves to function better.

It's too early to tell for sure whether the treatment could represent a standalone treatment for paralysis. It does, however, offer hope that in the futureperhaps when combined with drugs and physical therapythe treatment could help make paralysis a temporary, rather than permanent, condition. [New Scientist]

Image by Sebastian Kaulitzki/Shutterstock

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Spinal Stem Cell Injections Help Reverse Paralysis [Medicine]

2 of 3 spinal injury patients see gains in stem cell trial

Interim results from three patients in an early-stage trial of StemCells Inc's experimental cell treatment for chronic spinal cord injury show that two of them experienced gains in "sensory function," the company said.

StemCells is using neural stem cells, technically adult stem cells, taken from the partly developed brains of fetuses and tested for qualities showing they are destined to form particular types of nerve cells.

The company said that six months after being infused with the cells all three patients have tolerated the transplantation well and there are no safety concerns.

"We clearly need to collect more data to establish efficacy, but we are encouraged," Stephen Huhn, vice president at StemCells, said in a statement. He also said the company is pushing ahead with plans to dose patients with incomplete spinal cord injuries.

The initial phase of the trial involved patients with complete injuries and no neurological function below the level of the spinal injury.

Changes in sensitivity to touch, heat and electrical stimuli were observed in areas below the level of injury in two of the patients, while no changes were seen in the third patient, the company said.

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2 of 3 spinal injury patients see gains in stem cell trial

PropThink: Interim Data In Spinal Cord Injury Driving STEM Higher; PSTI Reacting in Sympathy

This morning, StemCells, Inc. (STEM) released six-month interim results for the first group of patients in its Phase I/II trial, testing the company`s HuCNS-SC (human neural stem cells) treatment candidate in patients with spinal cord injury - previous coverage available here. Shares are trading up nearly 20% in pre-market, and are likely to maintain momentum on the positive news. The interim data showed that thus far, HuCNS-SC treatment led to considerable gains in sensory function in two of three patients vs. their baseline levels of sensation prior to cell transplantation. The company also noted that the treatment continues to exhibit a favorable safety profile. The trial represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury, and the sensory gains observed have developed in a progressive pattern below the level of injury. Impressively, gains in sensation are not generally expected in spinal cord injury patients, particularly given the severity of injury seen in patients admitted to the Phase I/II study. According to STEM, sensory function of all patients observed thus far was stable before cell transplantation, therefore, the reappearance of sensation is a very positive sign that the treatment is having a beneficial effect. While the third patient did not experience an increase in sensation, that patient`s level of sensation remains stable. PropThink notes that another small-cap stem cell company, PluriStem Therapeutics (PSTI) is also moving in pre-market trading, likely in sympathy with the STEM news.

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PropThink: Interim Data In Spinal Cord Injury Driving STEM Higher; PSTI Reacting in Sympathy

AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury

BURLINGTON, Mass.--(BUSINESS WIRE)--

AlloCure, Inc. today announced that it has initiated a phase 2 clinical trial of AC607, the companys mesenchymal stem cell therapy, as a potential treatment for acute kidney injury (AKI). The randomized, double-blind, placebo-controlled, multi-center trial, designated ACT-AKI (AC607 Trial in Acute Kidney Injury) (NCT01602328), will enroll 200 cardiac surgery subjects at leading tertiary care centers in the United States.

ACT-AKI follows the positive results from a phase 1 AC607 trial in cardiac surgery subjects, which showed an excellent safety profile and encouraging data on the incidence of AKI and hospital length of stay, said Robert M. Brenner, M.D., AlloCure President and Chief Executive Officer. We have worked closely with leaders in the field on the design of ACT-AKI, and trial initiation represents an important milestone for AlloCure and the patients we collectively serve.

AC607 is a promising therapeutic candidate for AKI, for which effective therapies are greatly needed, said Richard J. Glassock, M.D., Emeritus Professor of Medicine at the Geffen School of Medicine at the University of California, Los Angeles. The initiation of ACT-AKI represents a critical step in the development of an innovative therapy for this all-too-common, serious and costly medical condition, for which no approved treatments currently exist beyond supportive care.

About AC607

AC607 is a novel biologic therapy under development for the treatment of AKI. AC607 also possesses potential applications in other grievous illnesses. AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a mature and state-of-the art manufacturing process. AC607 homes to the site of injury where it mediates powerful anti-inflammatory and organ repair processes via the secretion of beneficial paracrine factors, without differentiation and repopulation of the injured kidney. Importantly, AC607 avoids recognition by the hosts immune system, enabling administration in an off the shelf paradigm without the need for blood or tissue typing.

About AlloCure

AlloCure, Inc. is a privately held, clinical-stage biotechnology company focused on the treatment of kidney disease. The company is a leader in the AKI field and is pioneering the development of the first effective therapy for the treatment of AKI. The companys headquarters is located in Burlington, MA. For more information about AlloCure, please visit the companys web site at http://www.allocure.com.

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AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury

Cellerant Awarded $36.4 Million Option under Existing U.S. Government Contract to Support Development of CLT-008 for …

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded $36.4 million under an option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, for the advanced development of CLT-008, a first-in-class, allogeneic, cell-based therapy for the treatment of Acute Radiation Syndrome (ARS). This third year of funding is in addition to the $80 million committed under the two-year base period and is part of a five-year award valued at up to $169.9 million.

This additional funding will continue to support Cellerants CLT-008 development strategy by providing funds for its ongoing clinical trials, process development and manufacturing activities and the nonclinical studies required for approval in ARS. If licensed by the U.S. Food and Drug Administration (FDA), the federal government could buy CLT-008 for the Strategic National Stockpile under Project Bioshield. Project Bioshield is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.

We are pleased that the federal government continues to support our biodefense efforts to advance CLT-008, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. Our collaboration with BARDA over the past two years has been productive and this option exercise demonstrates BARDAs continued endorsement and satisfaction with the development and progress of CLT-008 as a potential medical countermeasure.

As part of BARDAs commitment to supporting multi-use products that have both commercial and biodefense applications, this third year of funding also allows Cellerant to continue its ongoing clinical trials with CLT-008 for cancer applications. Cellerants first Phase 1 study is evaluating CLT-008 in patients undergoing cord blood transplants for the treatment of hematological malignancies. CLT-008 is intended to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation. Cellerants second Phase 1/2 study is evaluating CLT-008 in acute leukemia patients with chemotherapy-induced neutropenia. CLT-008 may shorten the time to neutrophil recovery and decrease the risks of febrile neutropenia and infection.

In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation such as from a nuclear or radiological weapon, or from a nuclear accident. Various preclinical studies conducted to date suggest that a single dose of CLT-008 could provide effective treatment for ARS in an emergency situation, and could be administered up to five days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administrations Animal Efficacy Rule for ARS. This approval pathway requires demonstration of efficacy in representative animal models and safety and metabolism testing in human clinical trials. There is currently no FDA approved medical countermeasure to treat ARS.

About CLT-008

CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human myeloid progenitor cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In preclinical models, cryopreserved, allogeneic mouse myeloid progenitor cells have been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficacy. Cellerant is developing CLT-008 as a treatment for chemotherapy-induced neutropenia, protection following exposure to acute radiation, and facilitating engraftment of cord blood transplantation.

About Cellerant Therapeutics

Cellerant Therapeutics is a clinical stage biotechnology company focused on the regulation of the hematopoietic (blood-forming) system. The Company is developing human stem cell and antibody therapies for oncology applications and blood-related disorders. Cellerants lead product, CLT-008, is currently in two Phase 1 clinical trials in patients with hematological malignancies. The Company also has a cancer stem cell (CSC) antibody discovery program focused on therapies for acute myelogenous leukemia, multiple myeloma and myelodysplastic syndrome.

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Cellerant Awarded $36.4 Million Option under Existing U.S. Government Contract to Support Development of CLT-008 for ...

Stem cell jab

By Daily Mail Reporter

PUBLISHED: 12:03 EST, 4 September 2012 | UPDATED: 12:03 EST, 4 September 2012

Patients with broken spines have reported having feeling restored to areas that had previously been paralysed, after receiving stem cell injections.

Scientists said they were 'encouraged' after two of three patients injected with donated foetal brain tissue responded to treatment at Balgrist University Hospital in Zurich, Switzerland.

Each patient had around 20million neural stem cells delivered directly into their injured spinal cords between four and eight months after they were injured.

Early tests suggest stem cells could restore feeling to people with damaged spinal cords

Before the treatment none of the patients could feel anything below the nipples. Just three months after therapy two of the patients reported feeling some sensation. By six months they could detect both touch and heat between the chest and belly button. The third patient detected no changes.

Stephen Huhn, vice president of StemCells in Newark, California, that is developing the treatment told the New Scientist: 'The face we've seen responses to light touch, heat and electrical impulses so far down in two of the patients is very unexpected.

'They're really close to normal in those areas now in their sensitivity.'

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Stem cell jab

First Evidence that Adipose Stem Cell-Based Critical Limb Ischemia Treatment is Safe & Effective is published in …

SEOUL, South Korea, Sept. 4, 2012 /PRNewswire/ --Korean researchers, reporting the results of a major study in the Circulation Journal, found that the transplantation adipose (fat) derived stem cells resulted in the regeneration of blood vessels in patients who were otherwise expecting to receive limb amputations due to damaged arteries and lack of blood circulation.

Researchers at Pusan National University, led by Dr. Han Cheol Lee, describe how patients with critical limb ischemia (hereafter, CLI, example of which include Buerger's Disease and diabetic foot ulcers) were injected with adipose tissue-derived mesenchymal stem cell manufactured by RNL BIO.

As a result of the remarkable adipose stem cell process of RNL BIO, researchers found that immediate new blood vessel generation was identified. (The title of article is "Safety and Effect of Adipose Tissue-Derived Stem Cell Implantation in Patients With Critical Limb Ischemia")

CLI results from lack of circulation due to small artery damage and subsequent tissue necrosis. Patients with severe CLI often face limb amputation. Buerger's Disease, or diabetic foot ulcer, are of the same kind. Risk factors are diabetic mellitus, hypertension, high cholesterol and smoking. There is no known cure to date.

Currently percutaneous transluminal angioplasty or PTA may treat 60-70% of patients with CLI, but it doesn't work with those who suffer from Buerger's Disease. Working under approval to conduct compassionate use research of stem cell to treat CLI by intra-muscular injection of adipose tissue derived stem cells in December, 2008 (KFDA IND approval # 1273), the researchers in this study enrolled 15 subjects: 12 with Buerger's Disease, and 3 with Diabetic foot ulcers. 300 million stem cells were injected into each patient's leg. No complications were observed, even six months after injection.

Only five patients, as they all had expected, required minor amputation during follow-up, and all amputation sites healed completely. At 6 months, significant improvement was noted in pain and in claudication walking distance. Digital subtraction angiography before and 6 months after ATMSC implantation showed formation of numerous vascular collateral networks across affected arteries.

Dr. Jeong-Chan Ra, President of RNL Stem Cell Technology Institute, said, "This new therapy through adipose tissue derived mesenchymal stem cell is expected to offer new hope for patients with CLI, hope that had been difficult to find before."

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First Evidence that Adipose Stem Cell-Based Critical Limb Ischemia Treatment is Safe & Effective is published in ...

Global Human Embryonic Stem Cell (hESC) Research Industry

NEW YORK, Sept. 3, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Human Embryonic Stem Cell (hESC) Research Industry

http://www.reportlinker.com/p0960425/Global-Human-Embryonic-Stem-Cell-hESC-Research-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

This report analyzes the worldwide markets for Human Embryonic Stem Cell (hESC) Research in US$ Million. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2018. The report profiles 26 companies including many key and niche players such as Advanced Cell Technology, Inc., BD Biosciences, BioTime, Inc., Cell Cure Neurosciences Ltd., Cellartis AB, GE Healthcare, Millipore Corporation, Molecular Transfer, Inc., PerkinElmer, Inc., Pfizer, Inc., Research & Diagnostics Systems, Inc., Reliance Life Sciences Ltd., Stem Cell Network, Stemina Biomarker Discovery, Inc., UK Stem Cell Bank, and ViaCyte, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1

Disclaimers I-2

Data Interpretation & Reporting Level I-2

Quantitative Techniques & Analytics I-3

Product Definitions and Scope of Study I-3

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Global Human Embryonic Stem Cell (hESC) Research Industry

Stem cells bring back feeling for paralysed patients

For the first time, people with broken spines have recovered feeling in previously paralysed areas after receiving injections of neural stem cells.

Three people with paralysis received injections of 20 million neural stem cells directly into the injured region of their spinal cord. The cells, acquired from donated fetal brain tissue, were injected between four and eight months after the injuries happened. The patients also received a temporary course of immunosuppressive drugs to limit rejection of the cells.

None of the three felt any sensation below their nipples before the treatment. Six months after therapy, two of them had sensations of touch and heat between their chest and belly button. The third patient has not seen any change.

"The fact we've seen responses to light touch, heat and electrical impulses so far down in two of the patients is very unexpected," says Stephen Huhn of StemCells, the company in Newark, California, developing and testing the treatment. "They're really close to normal in those areas now in their sensitivity," he adds.

"We are very intrigued to see that patients have gained considerable sensory function," says Armin Curt of Balgrist University Hospital in Zurich, Switzerland, where the patients were treated, and principal investigator in the trial.

The data are preliminary, but "these sensory changes suggest that the cells may be positively impacting recovery", says Curt, who presented the results today in London at the annual meeting of the International Spinal Cord Society.

The patients are the first three of 12 who will eventually receive the therapy. The remaining recipients will have less extensive paralysis.

"The sensory gains, first detected at three months post-transplant, have now persisted and evolved at six months after transplantation," says Huhn. "We clearly need to collect much more data to demonstrate efficacy, but our results so far provide a strong rationale to persevere with the clinical development of our stem cells for spinal injury," he says.

"We need to keep monitoring these patients to see if feeling continues to affect lower segments of their bodies," says Huhn. "These are results after only six months, and we will follow these patients for many years."

Huhn says that the company has "compelling data" from animal studies that the donated cells can repair nerves within broken spines (Neurological Research, DOI: 10.1179/016164106X115116).

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Stem cells bring back feeling for paralysed patients