Stem Cell Trial
CLICK HERE for the first report of the Stem Cell Trial from the Glass Laboratory
VIDEO: The Promise of Stem Cells
February 1, 2012
We have completed surgery on our first Group D patient, who received injections of stem cells in to the cervical (neck) spinal cord on November 18th, 2011. Permission from the FDA for this major step forward was granted after their review of the safety data from our first 12 patients, who received stem cell injections into the lumbar (low back) spinal cord. Our experience from the lumbar injections demonstrated that lumbar spinal cord injections of neural stem cells are safe for patients with ALS. Now we are testing whether injections of stem cells into the cervical spinal cord will be equally safe. Cervical injections target the neurons that are connected to the breathing muscles. This is a “Phase I” trial, and our goal is limited to assessing the safety of stem cell transplantation into the spinal cord. The question of whether stem cell transplantation can ameliorate the disease process will be addressed during Phases 2 and 3.
We can report that there have been no unexpected complications as a result of surgery in the first 12 patients receiving lumbar spinal cord injections. The first six patients were in Group A. Three non-ambulatory (could not walk) patients received injections into one side of their spinal cord, and three non-ambulatory patients received injections into both sides. The next three patients were in Group B. These ambulatory patients received injections on one side of their spinal cord. The next three patients (Group C) were also ambulatory and received injections into both sides of their spinal cord.
Participants for Groups D and E will receive stem cell injections into the cervical spinal cord. The eligibility criteria for Group D are listed below. Patients are being considered by invitation only. All participants must fulfill all of the eligibility criteria.
Please understand this is only a partial list of the eligibility criteria. If you do not meet the following criteria, you will not be considered for enrollment. Due to the complexity of this study, priority will be given to current patients of the Emory ALS Center. Only people who live close to Atlanta will be considered.
Group D (up to 3 patients)
Eligibility Criteria:
1) Confirmed diagnosis of ALS by a neurologist
2) Vital capacity greater than 60% of predicted value seated; greater than 50% measured flat on your back
3) Difficulty walking due to ALS
4) Lack of complicating medical conditions
5) Live in geographic proximity to Emory University Hospital
6) Ability to communicate vocally or with low-tech tools (writing or letter board)
The consent form for Group D can be downloaded here: Stem Cell Consent Form
I have read the consent form and I meet the criteria for Group D. I would like to be considered as a participant. Please click here: Eligibility Form
For more information on the Stem Cell Trial click here.
