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Dear Mr ChristensenWe have now finished the first part of our clinical trial-the safety one and we are waiting for the approvals from the ministry of health in order to start the second part with a higher dose of cells.We still do NOT have the approval and we unfortunately do not know when! But at the moment will have it be sure that will discuss your case among the others with the committeeSincerelyPanayiota
We showed up at 10am at the international patient's office to work with our freind, Njoude, to schedule our appt with dr. Karussis. She arrived at 10:10 and smiled with a questioning look when she saw us waiting. When we showed her the email from dr Gotkine, she looked up at us with amazement and said "We win?" She then dialed dr K's office and spoke to his secretary, explaining the email. She hung up the phone and said we were to be at dr K's office in 30 mins. She also said "Maybe he agreed to see you because there is something he can do for you?" and, smiling while shrugging, said "We can only charge for visits after 1:30...so..." We thanked her and told her we'd be back.The visit itself went incredibly well! What we expected to be a confrontational meeting was anything but. After some initial questions about my history, a brief exam, and after reviewing Gotkine's notes, Dr. Karussis agreed that I am a strong candidate for the trial. He explained the difference between embryonic, mesenchymal, and partially-differentiated stem cells like the NurOwn cells used in the trial, and laid out my options in three buckets:
NurOwn trial:Following the release of positive initial safety data 2 months ago, study size and parameters are being renegotiated between BrainStorm, the Israeli Ministry of Health, and Hadassah. While this is being negotiated, Dr. K will take my case to the Hadassah selection committee and see if they agree I am a good fit. If they agree; if we move to Israel; and if there is a place in the study for me following negotiations (6 of 12 previously identified spots have been offered to other patients), I will be invited to participate. Treatment would take 4-6 months and would be limited to one treatment. There would be no cost to the patient.NurOwn 'compassionate use' treatment:Though the Israel Ministry of Health initially approved only three spots for 'CU', four individuals have been treated outside of the trial. Based on preliminary safety data, Dr. K is recommending that the IMoH expand the number of spots available for NurOwn treatment outside the trial. Brainstorm may prefer to limit the number of CU treatments due to the potentially negative impact on their pending FDA application. CU treatment would be less time intensive than treatment within the trial (taking 1-2 months), and would not necessarily be limited to one treatment. The patient may be asked to bare treatment costs if Brainstorm is not willing to pay.Mesenchymal (MSC) stem cell treatment:Dr. K claims some success in treating ALS with undifferentiated stem cells since 2006 (one patient has had no progression in 2 years due to multiple treatments). This would be the least time-consuming of the three options, but also carries unique risk--there have been cases of undifferentiated stem cells behaving badly after injection and causing cancer. The patient bares the cost of only some lab costs.
Of the three options, the compassionate use option seems most attractive due to its time requirements, and option for multiple treatments. This option depends on the Ministry of Health and Brainstorm agreeing on something that Brainstorm might be hesitant to agree to. Dr. K encouraged us to use what connection we have with BraunStorm to influence these decisions. Again, we will proceed one step at a time. We give thanks for these miraculous turn of events and are reminded to be at peace not knowing where they will lead us.