Tammie Caldwell from Raymondville, Texas was born on December 5, 1975 to parents who, unbeknownst to them, carried macular degeneration genes. Tammie was the second of their two children and at the age of 13 started to notice that her vision was deteriorating.
Over the years her vision continually got worse and it came to the point that at the age of 25 she was declared legally blind with 20/200 vision and now 12 years later it has deteriorated to 20/400. While her vision was worsening she underwent may eye-related examinations and was diagnosed with Stargarts disease. Stargarts disease, or fundus flavimaculatus, is an inherited juvenile macular degeneration that causes progressive vision loss usually to the point of legal blindness. The progression usually starts between the ages of six and twelve years old and plateaus shortly after rapid reduction in visual acuity.
Study experiments concerning Stargarts disease had been ongoing for a number of years and then finally on November 22, 2010 the US Food and Drug Administration (FDA) cleared the way for clinical trials using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt's Macular Dystrophy (SMD). "There is currently no treatment for Stargardt's disease,” said Dr. Robert Lanza. "Using stem cells, we can generate a virtually unlimited supply of healthy RPE cells, which are the first cells to die off in SMD and other forms of macular degeneration. We've tested these cells in animal models of eye disease. In rats, we've seen 100% improvement in visual performance over untreated animals without any adverse effects. Our studies showed that the cells were capable of extensive rescue of photoreceptors in animals that otherwise would have gone blind. Near-normal function was also achieved in a mouse model of Stargardt's disease. We hope to see a similar benefit in patients with various forms of macular degeneration.”
The clinical trials will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation to patients with advanced SMD. A total of twelve patients will be enrolled in the study at multiple clinical sites. The sites include the Jules Stein Eye Institute at UCLA (headed by Dr. Steven Schwartz); the Casey Eye Institute in Portland, Oregon (headed by Dr. Peter Francis of the Oregon Health Sciences University); the University of Massachusetts Memorial Medical Center in Worcester, Massachusetts (headed by Dr. Shalesh Kaushal, Chair of the Department of Ophthalmology); the UMDNJ - New Jersey Medical School in Newark, New Jersey (headed by Dr. Marco Zarbin, Chair, Institute of Ophthalmology and Visual Science); additional sites may be considered.
Tammie, through her own curiosity and research came upon a web site called fightingblindness.org and found out about the case studies that were being undertaken. In January of 2011 she applied for an opportunity to participate in the study. In mid-2011 Tammie was informed by the Oregon Casey Eye Institute that she was a potential candidate for the study.
That was great news for Tammie but the immediate problem was that she lived in Raymondville, Texas and the study she had been selected to take part in was in Portland, Oregon. She was excited and discouraged at the same time because she did not have the financial ability to not only get to Portland but also could not afford lodging and subsistence.
Tammy at that point didn’t know what to do. Her sister (who was not affected by the disease) and husband came up with the idea of having a BBQ to raise money for Tammie’s trip to Portland for the study. Tammie’s sister and brother-in-law went to a printer, Paul Whitworth, who owns the Raymondville Chronicle and asked advice on how to inexpensively print tickets for the BBQ. Mr. Whitworth, a member of the Raymondville Lions Club, offered up his Southwest Airlines frequent flyers miles to allow Tammie to get to Portland. Mr. Whitford also took Tammie’s plight to his Lions Club to see what they could do to help. Although she now has a ticket to Portland she did not have the ability to take care of lodging and subsistence.
Lions Club President Larry Spence asked Lion Club member Guy Fambrough to see if he could get the Oregon Lions to help in Tammie’s quest. Lion Guy contacted Texas Past International Director (PID) Mike Butler to talk to his contacts in Oregon about support. PID Mike contacted Oregon PID Dennis Tichenor. PID Dennis contacted Past Council Chair David Rich and his wife Penny and asked them if they would be willing to host Tammie while she was here. They agreed to host Tammie during her six-day stay and looked forward to the opportunity.
Tammie flew into Portland on February 29, 2012 with her first test scheduled at 8 am the next day. Her first exam, which lasted three hours, was the Visual Field (Peremetry) exam, which Perimetry is universally regarded as one of the most important visual assessments in many diseases, including inherited retinal degenerations.
Her next tests involved taking an Eletrotiogram (ERG) test. Electromyography (EMG) is a technique for evaluating and recording the electrical activity produced by skeletal muscles. An electromyography detects the electrical potential generated by muscle cells when these cells are electrically or neurologically activated. The signals can be analyzed to detect medical abnormalities, activation level, and recruitment order or to analyze the biomechanics of human or animal movement.
After two days of extensive tests Tammie was informed that she did qualify for, and would be admitted into, the test group if one last blood test proved that she had the proper chromosomes for the clinical trials.
Tammie was also put more at ease when she learned that her doctor (Dr. Pennesi) was from somewhere close to the region of the country where she was from, even if it was Oklahoma. On March 5, 2012 Tammie departed for Texas with the hope that she would be returning to continue the process. PCC David and Penny have agreed to once again to be her hosts when she returns to Oregon. PID Dennis and Judi along with PCC Keith and Denise Price also agreed to help with the hosting during the next phase, which could take up to six weeks to complete.
Tammie found out in late May that she was selected to continue as part of the study group and with the financial help from the Raymondville Lions Club made her way back to Portland on May 19, 2012 with her surgery scheduled for May 31, 2012. Between Tammie’s arrival and her surgery she went through a total of 21 different appointments, which were basically used to ensure the baseline for this study was consistent.
The surgery that was performed was done to deliver the actual gene replacement vector to stop the further deterioration of the eye. They operated on one eye only and the eye chosen is the one with the worse vision. Although the surgery was completed there Following the surgery Tammie had to report back the day after the surgery to have the patch removed and undergo another battery of tests then more post op tests after one week, two weeks and four weeks.
During this time Tammie first stayed with PCC David and Penny but from May 23rd to the 27th stayed with PCC Keith and Denise and David and Penny attended their grandsons High School Graduation in Linton, IN and then with PID Dennis and Judi from June 4th to June 11th when David and Penny took a planned vacation to Maui.
Tammie had her two week check up on June 13th and her vision in the eye that was operated on went from 20 over 250 to 20 over 160. A remarkable change. She, and all of involved, are extremely excited about the outcome and it might get better. Tammie returned to Raymondville on June 28th and will be coming back in late August for more testing. Although she is gone those that were touched by her will always feel her presence.
In Lions we say that we serve, but to be able to form a bond across geographical boundaries and agree to serve on the pure trust of your fellow Lions is very refreshing. That is why we do what we do without the thought of getting anything back out of the process.
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