sadiemae
Extremely helpful member
- Joined
- Sep 20, 2009
- Messages
- 2,527
- Reason
- Lost a loved one
- Diagnosis
- 09/2009
- Country
- US
- State
- NV
- City
- Reno
The old thread was closed, so here is the new info.
Neuralstem will begin stem cell injections into cervical spinal cord
Maryland biotherapeutics company Neuralstem announced Oct. 24, 2011, that it has received approval from the U.S. Food and Drug Administration (FDA) to begin transplanting stem cells into the cervical (neck) region of people with ALS.
This first U.S.-based trial of neural stem cells in ALS opened at Emory University in January 2010. It's designed to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in people with ALS.
Testing has progressed through increasing levels of risk. After reporting "smooth progress" in June 2011 for the first 12 trial participants, who received transplantations into the lumbar (lower back) region of the spinal cord, Neuralstem sought FDA approval to begin transplantation in the cervical spinal cord region.
Now, three people with ALS will receive injections on one side of the cervical region of the spinal cord. If results are favorable, the final three trial participants will receive injections on both sides of the cervical region.
"By moving the cell delivery to cervical spinal cord — the first time the FDA has approved intraspinal injections in this region — we will demonstrate that we can deliver our cells safely and routinely to all parts of the spinal cord," Karl Johe, Neuralstem Chairman and Chief Scientific Officer, said in an Oct. 24, 2011, Neuralstem press release.
Although the study is a safety trial, it is hoped that cervical injections may help with breathing and swallowing in ALS. Study investigators plan to evaluate any effects on motor and respiratory function.
Enrollment for this trial is still open; however, in addition to other criteria, only those who live in close proximity to Emory University (located in Atlanta, Ga.) will be considered for the trial. For details and contact information, see Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of ALS; or enter NCT01348451 into the search box at ClinicalTrials.gov.
Further details can be found at the Emory ALS Center website.
Neuralstem will begin stem cell injections into cervical spinal cord
Maryland biotherapeutics company Neuralstem announced Oct. 24, 2011, that it has received approval from the U.S. Food and Drug Administration (FDA) to begin transplanting stem cells into the cervical (neck) region of people with ALS.
This first U.S.-based trial of neural stem cells in ALS opened at Emory University in January 2010. It's designed to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in people with ALS.
Testing has progressed through increasing levels of risk. After reporting "smooth progress" in June 2011 for the first 12 trial participants, who received transplantations into the lumbar (lower back) region of the spinal cord, Neuralstem sought FDA approval to begin transplantation in the cervical spinal cord region.
Now, three people with ALS will receive injections on one side of the cervical region of the spinal cord. If results are favorable, the final three trial participants will receive injections on both sides of the cervical region.
"By moving the cell delivery to cervical spinal cord — the first time the FDA has approved intraspinal injections in this region — we will demonstrate that we can deliver our cells safely and routinely to all parts of the spinal cord," Karl Johe, Neuralstem Chairman and Chief Scientific Officer, said in an Oct. 24, 2011, Neuralstem press release.
Although the study is a safety trial, it is hoped that cervical injections may help with breathing and swallowing in ALS. Study investigators plan to evaluate any effects on motor and respiratory function.
Enrollment for this trial is still open; however, in addition to other criteria, only those who live in close proximity to Emory University (located in Atlanta, Ga.) will be considered for the trial. For details and contact information, see Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of ALS; or enter NCT01348451 into the search box at ClinicalTrials.gov.
Further details can be found at the Emory ALS Center website.
