Transplantation of spinal cord–derived neural stem cells for ALS

Favorited Transplantation of spinal cord–derived neural stem cells for ALS (neurology.org)
Analysis of phase 1 and 2 trials testing the safety of spinal cord transplantation of human stem cells in patients with amyotrophic lateral sclerosis (ALS) with escalating doses and expansion of the trial to multiple clinical centers.
I built the microinjectors used in these experiments for injecting stem cells into the first human patients.

CNN also has a general interest article talking about some of the results.

Links to some earlier articles:

Transplantation of spinal cord–derived neural stem cells for ALS

Analysis of phase 1 and 2 trials

Authors: Jonathan D. Glass, MD; Vicki S. Hertzberg, PhD; Nicholas M. Boulis, MD; Jonathan Riley, MD; Thais Federici, PhD; Meraida Polak, RN; Jane Bordeau, RN; Christina Fournier, MD; Karl Johe, PhD; Tom Hazel, PhD; Merit Cudkowicz, MD; Nazem Atassi, MD; Lawrence F. Borges, MD; Seward B. Rutkove, MD; Jayna Duell, RN; Parag G. Patil, MD; Stephen A. Goutman, MD; Eva L. Feldman, MD, PhD

ABSTRACT

Objective: To test the safety of spinal cord transplantation of human stem cells in patients with amyotrophic lateral sclerosis (ALS) with escalating doses and expansion of the trial to multiple clinical centers.

Methods: This open-label trial included 15 participants at 3 academic centers divided into 5 treatment groups receiving increasing doses of stem cells by increasing numbers of cells/injection and increasing numbers of injections. All participants received bilateral injections into the cervical spinal cord (C3-C5). The final group received injections into both the lumbar (L2-L4) and cervical cord through 2 separate surgical procedures. Participants were assessed for adverse events and progression of disease, as measured by the ALS Functional Rating Scale–Revised, forced vital capacity, and quantitative measures of strength. Statistical analysis focused on the slopes of decline of these phase 2 trial participants alone or in combination with the phase 1 participants (previously reported), comparing these groups to 3 separate historical control groups.

Results: Adverse events were mostly related to transient pain associated with surgery and to side effects of immunosuppressant medications. There was one incident of acute postoperative deterioration in neurologic function and another incident of a central pain syndrome. We could not discern differences in surgical outcomes between surgeons. Comparisons of the slopes of decline with the 3 separate historical control groups showed no differences in mean rates of progression.

Conclusions: Intraspinal transplantation of human spinal cord–derived neural stem cells can be safely accomplished at high doses, including successive lumbar and cervical procedures. The procedure can be expanded safely to multiple surgical centers.

Classification of evidence: This study provides Class IV evidence that for patients with ALS, spinal cord transplantation of human stem cells can be safely accomplished and does not accelerate the progression of the disease. This study lacks the precision to exclude important benefit or safety issues.

Source: Transplantation of spinal cord–derived neural stem cells for ALS

Stem cell treatment goes from lab to operating room | CNN.com

Bookmarked Stem cell treatment goes from lab to operating room by Miriam Falco, CNN Medical News Managing Editor (cnn.com)
Imagine having your back cut open, part of your spine removed, a stabilizing device that resembles a mini oil rig mounted on your back, the outer membrane of your spinal cord sliced open and experimental stem cells injected into it -- all for the advancement of science because it's not expected to benefit you.
Another article announcing the first stem cells being transplanted into a human patient in the United States. I worked with the researchers and surgeon in this experiment and built the microinjectors that were used in the lead up experiments as well as for this first patient.

First U.S. stem cells transplanted into spinal cord | CNN.com

Bookmarked First U.S. stem cells transplanted into spinal cord by Miriam Falco, CNN Medical News Managing Editor (cnn.com)
For the first time in the United States, stem cells have been directly injected into the spinal cord of a patient, researchers announced Thursday.
A recent article announcing the first stem cells being transplanted into a human patient in the United States. I worked with the researchers and surgeon in this experiment and built the microinjectors that were used in the lead up experiments as well as for this first patient.