Stem cell spine injections for MS - trial approved

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Main Category: Multiple Sclerosis
Also Included In: Stem Cell Research
Article Date: 17 Aug 2013 - 0:00 PDT Current ratings for:
Stem cell spine injections for MS - trial approved

The US Food and Drug Administration (FDA) has approved a new clinical trial of a groundbreaking strategy using stem cells for the treatment of MS (multiple sclerosis).

Researchers from the Tisch MS Research Center of New York say the FDA has granted approval to begin early clinical investigation (phase 1 trial) of autologous neural stem cells in the treatment of MS.

Multiple sclerosis is a chronic disease that attacks the central nervous system (the spinal cord, optic nerves and brain). Common symptoms are numbness of the limbs, but more severe cases can lead to paralysis and blindness.

According to the Multiple Sclerosis Foundation, there are currently between 350,000 to 500,000 people in the US who have been diagnosed with MS, and 200 people are diagnosed with the disease every week.

The new regenerative strategy will involve using autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs), which will be harvested from the bone marrow of 20 MS patients who meet the criteria for the trial.

The stem cells will then be injected into the cerebrospinal fluid that surrounds the spinal cords of the patients.

The main objective of the clinical trial, the researchers say, is to determine the safety of the treatment, while the secondary objective is to measure the effectiveness.

The injections will be repeated at 3-month intervals, with their safety and efficacy frequently monitored through follow-up visits. After the final injection, patients will be monitored for up to 27 months.

Preclinical testing of this procedure showed that after injecting the stem cells, brain inflammation was reduced in seven MS patients, myelin was repaired (an insulating layer that forms around nerves), and protection of the neuronal structure and function of the brain was improved.

Dr. Saud Sadiq, senior research scientist at Tisch MS Research Center of New York, says:

"This study provides a hope that established disability may be reversed in MS."

Similar trials but with larger number of patients (phase 2) have already been under way in the UK. In 2011, UK scientists received £1 million from the MS Society and the UK Stem Cell Foundation (UKCSF) towards research investigating whether stem cells can slow, stop or reverse brain and spinal cord damage in MS patients.

Dr. Sadiq says of this most recent trial in the US:

"To my knowledge, this is the first FDA-approved stem cell trial in the United States to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment."

The clinical trial will begin enrolling patients once ethical approval has been granted and funding secured.

Written by Honor Whiteman

Copyright: Medical News Today
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Low Risk Ankle Rule clinical trial

Main Category: Bones / Orthopedics
Also Included In: Radiology / Nuclear Medicine;  Pediatrics / Children's Health
Article Date: 14 Aug 2013 - 0:00 PDT Current ratings for:
Low Risk Ankle Rule clinical trial

Radiography is widely used in diagnosing ankle injuries, with 85%-95% in pediatric injuries, although only 12% of these show fractures.

"Radiography is unnecessary for most children's ankle injuries, and these high rates of radiography needlessly expose children to radiation and are a questionable use of resources," writes Dr. Kathy Boutis, a pediatric emergency department physician at the Hospital for Sick Children (SickKids) and the University of Toronto, with coauthors.

The Low Risk Ankle Rule is highly accurate at identifying fractures and can potentially reduce the need for radiography by 60%. It states that if a child with an ankle injury has a low-risk examination, ankle radiography may not be necessary to further exclude a high-risk ankle injury. If a subset of minor lateral ankle fractures is missed, evidence shows that these are exceptionally stable and low risk for any future issues and can be treated like an ankle sprain. Reducing radiography can lower exposure to low levels of radiation, contain costs and speed up treatment.

Researchers implemented the Low Risk Ankle Rule in 6 Canadian emergency departments to determine whether it reduced the use of radiography in children. The study involved 2151 patients (1055 at intervention and 1096 at control sites) between the ages of 3 and 16 years who presented at an emergency department with a nonpenetrating ankle injury. By applying the rule, the use of ankle radiography was reduced by about 22%. This reduction was consistent in different emergency departments and is similar to the Ottawa Ankle Rule used with adults.

"The implementation of the Low Risk Ankle Rule led to a significant decrease in imaging, associated increase in clinically important fractures being missed or decrease in patient or physician satisfaction," write the authors. "The ankle rule has potential broad applicability to emergency departments throughout most of the developed world, and widespread implementation of this rule could safely lead to reduction of unnecessary radiography in this radiosensitive population and a more efficient use of health care resources."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our bones / orthopedics section for the latest news on this subject.

Effect of the Low Risk Ankle Rule on the frequency of radiography in children with ankle injuries

Kathy Boutis, Paul Grootendorst, Andrew Willan, Amy C. Plint, Paul Babyn, Robert J. Brison, Arun Sayal, Melissa Parker, Natalie Mamen, Suzanne Schuh, Jeremy Grimshaw, David Johnson, Unni Narayanan. CMAJ August 12, 2013 First published August 12, 2013, doi: 10.1503/cmaj.122050

Canadian Medical Association Journal

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Adaptimmune announces opening of Phase I/IIa clinical trial in ovarian cancer

Main Category: Clinical Trials / Drug Trials
Also Included In: Ovarian Cancer
Article Date: 29 Jul 2013 - 2:00 PDT Current ratings for:
Adaptimmune announces opening of Phase I/IIa clinical trial in ovarian cancer

Adaptimmune has announced that it has opened a Phase I/IIa, multiple-site, two-cohort, open-label clinical trial in ovarian cancer at Roswell Park Cancer Institute (RPCI) in Buffalo, N.Y., and City of Hope (COH) in Duarte, Calif.

Researchers will investigate the safety, bioactivity and effectiveness of treating patients with their own T cells after genetically engineering the cells to enhance their anti-tumor properties.

"T cells are the foot soldiers of the human immune system, attacking invaders like bacteria, viruses and cancer," says Kunle Odunsi, MD, PhD, Director of RPCI's Center for Immunotherapy and the study chair. "We believe that by modifying the T cells so that they express a high-affinity receptor for a protein that is a known cancer/testis (CT) antigen, we can fully exploit their ability as cancer killers."

During the trial, T cell receptors (TCRs) that have been developed using Adaptimmune's unique TCR enhancement technology will be deployed to target two CT antigens, NYESO-1 and LAGE-1. They will be transferred to the patients' T cells in a process for autologous T cell manufacturing developed by Carl June, MD, and Bruce Levine, PhD, at the Perelman School of Medicine at the University of Pennsylvania, Pa., and then licensed to Adaptimmune. Manufacturing will be performed centrally by Progenitor Cell Therapy in Allendale, N.J.

Adaptimmune is the regulatory sponsor, owns the core T cell receptor technology, and is funding the study. Dr. Odunsi is the lead clinical investigator at RPCI and protocol Chair. Mihaela Cristea, MD, associate clinical professor, Medical Oncology, is the lead clinical investigator at City of Hope.

The study is opening on the heels of promising clinical data emerging in sarcoma and myeloma studies, where the same engineered T cell product is under investigation. Interim data from these studies was presented at the American Association for Cancer Research Annual Meeting in March and American Society for Cell and Gene Therapy Annual Meeting in May of this year.

Ovarian carcinoma is the fourth-most-common cancer in women, accounting for approximately 22,000 new cases and 15,000 deaths per year in the United States. With standard therapy, long-term response rates are low, and the five-year survival rate for advanced ovarian cancer is only 30%. The clinical trial focuses on this unmet medical need and will include patients who are resistant to chemotherapy and/or have received more than two lines of chemotherapy for their ovarian cancer.

Infusion of the CT antigen-specific T cells will occur following a brief treatment with relatively high dose of "lymphodepleting" chemotherapy to prepare the patient's immune system for the gene-modified T cells. Previous clinical trials for different cancer indications have demonstrated that the lymphodepleting chemotherapy procedure is safe and promotes reconstitution of the immune system with the gene-modified T cells.

Dr. Odunsi is also the Chair of Gynecologic Oncology at RPCI and has been studying NY-ESO-1 vaccines in immunotherapy clinical trials for ovarian cancer patients since 2002. "NY-ESO is a very promising tumour antigen that I have worked with for years under the umbrella of the Cancer Vaccine Collaborative (CVC) Program of the Cancer Research Institute and the Ludwig Institute for Cancer Research," says Dr. Odunsi. "This technology basically allows us to genetically engineer a powerful T cell response in patients against the NY-ESO-1 antigen, which is very exciting."

Stephen J. Forman, MD, director of the T Cell Therapeutics Research Laboratory at City of Hope, initially brought the Adaptimmune technology to City of Hope due to his long-standing interest in adoptive and engineered T cell therapy for cancer. "The evaluation of this therapy in both hematologic and solid tumors will help us to understand the function of the engineered T cells in different tumor settings," says Dr. Forman, chair of the Department of Hematology & Hematopoietic Cell Transplantation and holder of the Francis and Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation. "I'm very enthusiastic to have this study join our programs at City of Hope, and to be able to offer our patients these novel and promising therapies."

A myeloma study using this technology is also planned at the site.

A total of six patients will be enrolled in the ovarian trial. Only patients capable of responding to the therapy - those with the correct tissue marker (HLA-A*0201) and whose tumor expresses NY-ESO-1 and/or Lage-1 - will be enrolled. Enrollment is expected to complete within six to nine months. If data are promising, the study may be extended to include more patients.

"We are enormously pleased to be working with world leaders in immunotherapy for cancer," says James Noble, CEO of Adaptimmune. "Ovarian cancer is an important clinical indication with which to evaluate our CT antigen specific TCRs because of the dismal prognosis of current standard care for advanced ovarian cancer, so the effects of the T cell immunotherapy can be rapidly assessed."

Additional study details and contact information for patients interested in finding out more about participation can be found at clincialtrials.gov, under trial identifier number NCT01567891.

Both City of Hope and Roswell Park Cancer Institute are National Cancer Institute-designated Comprehensive Cancer Centers.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our clinical trials / drug trials section for the latest news on this subject.

Clinical trial: Autologous T Cells Expressing Enhanced TCRs Specific for NYESO-1/LAGE in Patients With Ovarian Cancer

Dr. Kunle Odunsi, Dr. Cristea and Dr. Forman have no financial interest or other relationship with Adaptimmune Ltd, apart from their scientific collaboration in conducting laboratory experiments and planning human clinical trials.

Adaptimmune

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