Emory Stem Cell Trial Phase 1

[Gusflower]

Emory ALS Center: ALS Research

Message Regarding Stem Cell Trial: Updated 1 March 2011

We have begun the phase I trial of spinal cord derived stem cells for patients with ALS. We have now completed ten patient surgeries and we can report that all are doing well as of this date. The first six patients were in Group A. Three non-ambulatory 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. One patient in Group C, another ambulatory patient, has received injections into both sides of their spinal cord. We are preparing for the final two patients in Group C and anticipate this group will be complete in the next couple months. We are actively seeking participants for the final two groups of this study.

We began this trial with those who had severe disability and thus were at a lower risk for added weakness that may occur as a consequence of stem cell injection into the spinal cord. We are now moving forward with patients with less disability. As we move forward, the eligibility criteria will change for future groups. This information 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. Thank you for your interest and your support in moving this important trial forward.

We are now recruiting for Group C (3 patients). Patients participating in this group will 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 C is listed below. Eligibility criteria for Group D will be posted soon.

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 C (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)

 

[Bad Balance]

Sounds like I would fit the criteria and I live near Emory. I am being treated in the Emory ALS Clinic currently?

Yeas and Neas on this? What would be the downside do you think?

 

[Alyoop]

Bad balance. As it's phase I the downside is, that you may not benefit physically,in anyway yourself. It's time consuming for the patient, the procedures can be painful. Adverse events can occur, etc etc.

The upside is that you are doing something positive for yourself and others. Participants in phase I studies are all heroes as far as I am concerned. They are putting others first with no gain for themselves.

Go for it. I certainly would not hesitate if I had the chance.
Aly
(clinical trials are what I do for a job)

 

[trfogey]

Sounds like I would fit the criteria and I live near Emory. I am being treated in the Emory ALS Clinic currently?

Yeas and Neas on this? What would be the downside do you think?

You might want to talk to TedH5 about this trial, BB. If this isn't the trial he's supposed to be starting shortly, then it is very similar to his.

Kind of surprising that your clinic hasn't approached you about it already if you qualify. Right hand not knowing what the left hand is doing, I suppose.

 

[TedH5]

Badbalance, this is the trial I am doing. As they said they have done 10 patients and I am patient # 11. I am suprised that they did not talk to you about it at your clinic visit or when you were diagnosed. Reach out to Crystal Kelly at the clinic she coordinates the research projects for Dr. Glass and shcedules the research patients to be seen by the staff.

The next phase they are referring to is patients 13 - 18. Instead of receiving injections in the lumbar section of the spine you will receive them in the cervical area of your spine. Remember this is a safety study but showed great promise in mice and rats. So while it will provide hope if you go in to it with the expectation it will cure you then you will be disappointed. Any specific questions let me know, my procedure is next Wednesday the 9th.

 

[Gusflower]

I wish you will feel better after this TedH5!

 

[Bad Balance]

I was contacted today by Emory about participating in the stem cell cervical study.

Lots to think on.

 

[TedH5]

Thats great! From what I hear the cervical portion holds hope that it will help peoples lungs. Although at the end of the day it is about safety and that is what they will stress. I would definitely go for it. Any questions let me know I am here for you! Good luck!