Message Regarding Stem Cell Trial: Updated June 1, 2010
We have begun the phase I trial of spinal cord derived stem cells for patients with ALS. We have now completed four patient surgeries and we can report that all are doing well as of this date. Three patients received unilateral injections, and one patient received bilateral injections into the spinal cord. We are preparing for an additional two patients to undergo bilateral injections (this is group 2A). The selection criteria for participants for group (2A) are listed below. In addition, we are now recruiting for Group B (3 patients). Patients participating in Group B should have difficulty walking, but be able to walk without the assistance of another person and have good breathing function. The selection criteria for participants for group B are listed below.
We are beginning with those who have severe disability and thus are at a lower risk for added weakness that may occur as a consequence of stem cell injection into the spinal cord. Future groups will have different eligibility criteria, which will be posted on this website as the trial progresses.
Those interested in the trial should understand that this is purely a "safety trial" (phase I in medical terminology) to see if injection of cells into the spinal cord is safe in people with ALS. Our plan is to enroll one patient at a time, up to a possible total of 12 patients, to test the safety of the surgical procedure and the cells to be injected. Thank you for your interest and your support in moving this important trial forward.
Group 2A (up to 3 patients)
Eligibility Criteria:
1) Confirmed diagnosis of ALS by a neurologist
2) Has tracheostomy and is ventilator dependent for greater than 3 months OR a vital capacity greater than 60% predicted value
3) Unable to walk 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)
7) A willing and able caregiver who is committed to the study.
Stem Cell Consent Form
I have read the consent form and I meet the criteria for Group 2A. I would like to be considered as a participant. Please click here: Eligibility Form
Group B (up to 3 patients)
Eligibility Criteria:
1) Confirmed diagnosis of ALS by a neurologist
2) Vital capacity greater than 60% of predicted value
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)
Stem Cell Consent Form
I have read the consent form and I meet the criteria for Group B. I would like to be considered as a participant. Please click here: Eligibility Form
