FDA Advises Tisch MS Research Center to March On: Preparation to Begin for Phase II of Stem Cell Trial for MS
January 15, 2016 By Cade Hildreth (CEO)
http://www.bioinformant.com/fda-advises-tisch-ms-research-center-to-march-on-preparation-to-begin-for-phase-ii-of-stem-cell-trial-for-ms/
Dedicated to identifying the cause of multiple sclerosis (MS), the Tisch MS Research Center of New York was formally launched in 2006. However, it grew out of the MS center at the Neurological Institute of New York of the Columbia University Medical Center, a group which Dr. Saud Sadiq joined in 1992. Since that time, Dr. Sadiq has moved his research from a small 320 square foot laboratory into a 15,030 square foot facility that is now a not-for-profit research entity and the largest independent MS center in the world.
Importantly, the research center is paired with a clinical affiliate, the International Multiple Sclerosis Management Practice (IMSMP), of which Dr. Sadiq is also director. Though this clinical affiliate, thousands of MS patients now receive cutting-edge, comprehensive MS care.
In breaking news released January 13th, 2016, Dr. Sadiq announced that the Tisch MS Research Center of New York will be pursuing a Phase II clinical trial exploring the use of stem cells in the treatment of MS. The announcement followed positive results from a FDA-approved Phase I stem cell trial. In this Phase I trial, MS patients received multiple spinal injections of neural progenitors derived from bone marrow mesenchymal stem cells (called MSC-NPs).
In addition to demonstrating positive safety and tolerability data, this Phase I trial was the first time in history that a treatment showed reversal of established disability in MS patients. Phase I patients were observed to have clinical improvements in ambulatory function, limb strength, and bladder control, among other improvements.
With permission from the Tisch MS Research Center of New York, the full press release about this groundbreaking stem cell research is included below.
FDA Advises Tisch MS Research Center to March On: Preparation to Begin for Phase II of Stem Cell Trial for MS
Encouraging Results from Phase I Show Reversal of Disability and Repair of Damage Caused by Multiple Sclerosis
Press Release; New York, NY – January 13, 2016 — Tisch MS Research Center of New York (Tisch MSRCNY) announced today that it will pursue Phase II of its clinical trial, the first stem cell treatment for MS in the United States ever to move to this stage. Following the establishment of safety and tolerability in Phase I with no adverse effects, the Food and Drug Administration (FDA) advised Tisch MSRCNY to continue with its research.
“Our unprecedented Phase I results have propelled us into the next phase of research,” said Dr. Saud A. Sadiq, Chief Research Scientist at Tisch MSRCNY and the study’s principal investigator. He added, “No treatment has shown reversal of established disability in MS until now. The objective improvement experienced in bladder function, vision and walking speed in both secondary and primary progressive MS is remarkable. We now plan to establish efficacy of stem cells as a reparative therapy in Phase II.”
The Phase II trial will be a double-blind, placebo-controlled, randomized trial with forty patients in a crossover design. Stem cells are taken from the patient’s bone marrow and manipulated to become brain-like neural cells, a process created and found only at Tisch MSRCNY. All treatments and research will be conducted at the Tisch MS Research Center of New York and will expand to include an additional leading MS center.
The main obstacle in initiating the study is the need for critical funding. Once funding is obtained, patients will be recruited and the study is anticipated to commence in the summer of 2016.
About Tisch MS Research Center of New York
For over twenty years, Dr. Saud A. Sadiq has believed that combining clinical excellence with innovative research targeted at finding the cure for multiple sclerosis would set an exemplary standard for healthcare. Today, Tisch MS Research Center of New York embodies this new model. The close relationship of the non-profit research center and its affiliated clinical practice, the International Multiple Sclerosis Management Practice, enables the testing of new MS treatments and accelerates the pace at which research discoveries move from lab bench to bedside. Tisch MS Research Center of New York aims to find the cause of MS, optimize treatments for patients, and repair the damage caused by multiple
Media Inquiries: Pamela Levin, RN 646-557-3891, plevin@tischms.org
January 15, 2016 By Cade Hildreth (CEO)
http://www.bioinformant.com/fda-advises-tisch-ms-research-center-to-march-on-preparation-to-begin-for-phase-ii-of-stem-cell-trial-for-ms/
Dedicated to identifying the cause of multiple sclerosis (MS), the Tisch MS Research Center of New York was formally launched in 2006. However, it grew out of the MS center at the Neurological Institute of New York of the Columbia University Medical Center, a group which Dr. Saud Sadiq joined in 1992. Since that time, Dr. Sadiq has moved his research from a small 320 square foot laboratory into a 15,030 square foot facility that is now a not-for-profit research entity and the largest independent MS center in the world.
Importantly, the research center is paired with a clinical affiliate, the International Multiple Sclerosis Management Practice (IMSMP), of which Dr. Sadiq is also director. Though this clinical affiliate, thousands of MS patients now receive cutting-edge, comprehensive MS care.
In breaking news released January 13th, 2016, Dr. Sadiq announced that the Tisch MS Research Center of New York will be pursuing a Phase II clinical trial exploring the use of stem cells in the treatment of MS. The announcement followed positive results from a FDA-approved Phase I stem cell trial. In this Phase I trial, MS patients received multiple spinal injections of neural progenitors derived from bone marrow mesenchymal stem cells (called MSC-NPs).
In addition to demonstrating positive safety and tolerability data, this Phase I trial was the first time in history that a treatment showed reversal of established disability in MS patients. Phase I patients were observed to have clinical improvements in ambulatory function, limb strength, and bladder control, among other improvements.
With permission from the Tisch MS Research Center of New York, the full press release about this groundbreaking stem cell research is included below.
FDA Advises Tisch MS Research Center to March On: Preparation to Begin for Phase II of Stem Cell Trial for MS
Encouraging Results from Phase I Show Reversal of Disability and Repair of Damage Caused by Multiple Sclerosis
Press Release; New York, NY – January 13, 2016 — Tisch MS Research Center of New York (Tisch MSRCNY) announced today that it will pursue Phase II of its clinical trial, the first stem cell treatment for MS in the United States ever to move to this stage. Following the establishment of safety and tolerability in Phase I with no adverse effects, the Food and Drug Administration (FDA) advised Tisch MSRCNY to continue with its research.
“Our unprecedented Phase I results have propelled us into the next phase of research,” said Dr. Saud A. Sadiq, Chief Research Scientist at Tisch MSRCNY and the study’s principal investigator. He added, “No treatment has shown reversal of established disability in MS until now. The objective improvement experienced in bladder function, vision and walking speed in both secondary and primary progressive MS is remarkable. We now plan to establish efficacy of stem cells as a reparative therapy in Phase II.”
The Phase II trial will be a double-blind, placebo-controlled, randomized trial with forty patients in a crossover design. Stem cells are taken from the patient’s bone marrow and manipulated to become brain-like neural cells, a process created and found only at Tisch MSRCNY. All treatments and research will be conducted at the Tisch MS Research Center of New York and will expand to include an additional leading MS center.
The main obstacle in initiating the study is the need for critical funding. Once funding is obtained, patients will be recruited and the study is anticipated to commence in the summer of 2016.
About Tisch MS Research Center of New York
For over twenty years, Dr. Saud A. Sadiq has believed that combining clinical excellence with innovative research targeted at finding the cure for multiple sclerosis would set an exemplary standard for healthcare. Today, Tisch MS Research Center of New York embodies this new model. The close relationship of the non-profit research center and its affiliated clinical practice, the International Multiple Sclerosis Management Practice, enables the testing of new MS treatments and accelerates the pace at which research discoveries move from lab bench to bedside. Tisch MS Research Center of New York aims to find the cause of MS, optimize treatments for patients, and repair the damage caused by multiple
Media Inquiries: Pamela Levin, RN 646-557-3891, plevin@tischms.org