Updated 5/1/2021, first version published 8/20/2019
I’ve found 30 responders to NurOwn (below). Mike Henson, who tracks cases closely, cites 40. On Feb. 22, 2021, the FDA denied NurOwn, even though NurOwn showed statistical significance in 35% of trial participants and worked in many of the other participants (ie, NurOwn works). The FDA’s denial is absurd, even ignoring the brutality of ALS. Same story with AMX00035 and Alzheimer’s aducanumab. FDA has approved less effective drugs with harsher side effects, which is why we need a congressional hearing ASAP. Join the red tape movement if you haven’t already.
- Person 1: Matt Bellina—First and only person to get it in US outside of the trial. There is no possible way to argue NurOwn didn’t work in him. Increased slowing of progression after 4th and 5th injections. Lung function improved by 10 percent. ALSFRS-R score did not go down while on treatment.
Here’s Matt with #3 below (Mark) on May 25, 2020: https://twitter.com/Markbedwell11/status/1265110664470835200
See later portion of this video: https://youtu.be/uZTA-g33MhE
A late 2020 statement from Matt: I have not had a (NurOwn) treatment in about six months. In February I got pneumonia and spent eight days in ICU. We thought I lost all my gains but I actually recovered thank God. Can still stand and today I did 9 miles on a recombent elliptical. Both things I couldn’t do 18 months ago.
- Person 2: Mike Cimbura—Was in Phase 2 trial. DIED WAITING. Went from not being able to use his hands to being able to lift them above head, comb his hair. He was unable to access the treatment after the trial and passed away in March 2019. https://www.denverpost.com/2016/12/05/our-dad-has-als-the-senate-could-help-by-reforming-fda-drug-approval/
- Person 3: Mark Bedwell—Could barely walk, had difficulty speaking and now runs around a conference table, speech markedly improved: https://philadelphia.cbslocal.com/2019/03/11/als-patients-fighting-fda-for-experimental-drug-nurown/
- Person 4: Bobby Forster—Was in phase 2. Probably the most famous responder. Couldn’t walk pre-trial; could walk after trial. https://whatsupnewp.com/2016/10/bobby-im-dying-deserve-right-try/
- Person 5: Eric Stevens—Was in phase 3, a firefighter who formerly played in the NFL for the St. Louis Rams. Leading up to the trial, Eric was progressing rapidly. His left hand was getting weaker, speech was slurring, fasciculations were spreading, and his legs were giving out. While in the trial Feb – Sept 2020, these things (left hand, speech, fasciculations, and legs) did not get any worse. When off the treatment Dec 2020 – today (Feb 2021) timeframe, the progression picked up speed again. See minute 17 of https://youtu.be/1TDWRx14_rk (this is Amanda, Eric’s wife).
- Person 6: Thurman Maynard—Was in Phase 3. Couldn’t ride motor cycle for 2 years but now can (couldn’t work clutch but now can, couldn’t stand on toes but now can). Says he knows what he lost, knows what he gained, knows NurOwn worked.
Interviewed Aug 10, 2020: https://www.wowktv.com/news/local/father-and-husband-in-the-fight-of-his-life/
Interviewed on Nightline in Aug. 2019. https://abcnews.go.com/Nightline/video/als-patient-rides-motorcycle-unable-years-part-64874209
- Person 7: Rome Milan—DIED WAITING. Progression stopped for 14 months while in the trial https://twitter.com/als_now/status/1387250960225996803.
- Person 8: Phil Green—Was in phase 3. He said his progression slowed during his time in the phase 3 trial. Talked to him personally about it and he also posted in social media: Imagine being in a clinical trial that stopped the progression of your ALS (3rd party data supported) & now have to wait a year+ before it may get FDA approval. While I wait, I am losing my ability to walk, speak, & breathe. @HollyLynchez your “FDA Gatekeeping” is killing me. https://www.biospace.com/article/nurown-a-study-in-the-complexity-of-als-trials-/
- Person 9: Rabbi Refael Shmulevitz. Quite famously helped him https://twitter.com/silverberg_matt/status/1186120947050438657?s=20
- Person 10: Dawn Boushelle—Phase 3 trial participant and scientist. She gives a long interview at https://youtu.be/05Nx3Xpzjy4 where she says that she is positive NurOwn gave her 6-8 months more living. The 6 months she was in the trial, her progression halted. It resumed immediately after the trial ended. They haven’t told her whether or not she got the placebo, but they (Brainstorm) told her that after week 14 the placebo effect ceases. Two months after her last treatment, Dawn could no longer open water bottles, problems in her leg began, etc.
- Person 11: Terri P—Says NurOwn stopped her progression. Hiding her last name ’cause don’t know whether she went public.
- Person 12: Sandy Morris—Progression was fast before and after NurOwn trial but stopped while she was taking NurOwn. She talks about it in her Twitter feed: https://twitter.com/sandymorris333/status/1413920501160833027?s=20
- Person 13: Roberto Muggli—Three weeks after 1st injection could move affected arm (right arm) more easily. Six to seven months after the trial, zero progression in his right arm, which was the only body part that’s been affected. Also went from having to elevate upper body at night (pre-trial) to normal sleep position (post trial). Estimates his fasciculations decreased by 60-70%.
- Person 14: Kade Simons—Says the trial effects had a drastic impact on his symptoms (fasciculations stopped upon needle being pulled out each dose, speech, tongue control, bladder control (and a whole bunch of other stuff he names) were improved. Effects lasted about 6 weeks. He has a fast progression. The video is interesting and he and his mom are such sweeties: https://www.youtube.com/watch?v=WOWsU1VW8bc
- Persons 15-17—The three advanced-stage Israelis whose conditions markedly improved (which includes Omri Chotam) as reported in ‘The soldier and the rabbi’ section of this article: https://www.israel21c.org/revolutionary-stem-cell-als-treatment-begins-advanced-trials/ (thank you for this info, Shah). The fourth person the article mentions is already mentioned as my #14.
- Person 18: Cathy Martin—Says her progression stopped during the injections and continued on again when she stopped the injections. https://youtu.be/0Cl3gqKZ-wo.
- Person 19 – Betsy McCormick—During her time in the trial her progression stopped. See minute 22 of https://youtu.be/1TDWRx14_rk (this is Betsy herself describing the positive results). Betsy’s a professor at the University of Tulsa.
Additional info about Betsy: https://youtu.be/GBaiKqfP1DUhttps://cdn.transistor.fm/file/transistor/m/shows/1727/4f3254f9b720862712f0f385d3c449e8.mp3.
- Person 20: Eric Swarz—Started noticing improvement in hand function a month after first treatment (could be placebo effect but then it’s a strong one in this case). https://abc7.com/health/uci-researchers-studying-ways-to-slow-the-progression-of-als-/3302128/
- Person 21: Mark Harrison—https://twitter.com/marksberardi/status/991861888597323776?s=20.
- Person 22: Josh Smith—Similar to person 9 in this list. Had a fast progression prior to the first injections. During the injection months, the progression stopped. https://youtu.be/uZTA-g33MhE
- Person 23: Trevor Stoffer—Saw dramatic improvements for a month after the first injection. Could move much better and his muscle spasms (which were intense leading up to the injection) stopped for a month: https://youtu.be/_HgkEPu1BlE
- Person 24: Noel Mermer—In his own words at https://www.charlestoncitypaper.com/charleston/a-note-from-city-paper-publisher-noel-mermer/Content?oid=25553823, it slowed his progression:
A close friend helped me gain access to the trial [at Mass Gen], which was a first of its kind. My stem cells were harvested and sent to the City of Hope, Calif., where they were grown and then injected back into my spinal cord. This trial involved 14 trips to Boston over a 12-month period — I was the first person in the U.S. to complete the trial. Throughout, we felt that the stem cells were slowing the progression of the disease, and that I was one of the lucky ones receiving my own stem cells as opposed to the placebo. Unfortunately, after the completion of the year-long study, my stem cells were no longer available to me.
- Person 25: Gayle Boone—Galye was in Phase 3 and says it works, says, “My decline stopped while receiving treatments.” She says it should be rolled out now. https://twitter.com/GayleBoone12/status/1265091114589212675
- Person 26: Ryoichi Hosoya—Saw improvements in function while on trial. Saw reversal and slowing of progression while in trial. https://www.squamishchief.com/community/hope-for-an-als-cure-for-squamish-ski-instructor-and-others-like-him-1.24146741. https://twitter.com/hosoyawinnie?lang=en
- Probable 27-30 (5 more responders) from Mike’s list. But he gives only initials to protect privacy: NL, GP, JM, SC. I can’t independently confirm but I trust Mike.
- Possible persons 31 and 32—Two ladies who do not wish to go public, cited in a meeting of an organization I belong to. Might be separate but I suspect this is referring to Cathy Martin.
- Possible person 33—I saw another person NurOwn has worked on who attended the No More Excuses protest June 12. I’ll try to track down their name. Might be a duplicate of one of the above.
- Possible person 34—Dawn mentions another Phase 3 participant she talked with during the trial who went from not being able to walk at for 15 months to walking again. Might be a duplicate.
The above are just those I stumbled upon. There are probably several more. Only about 160 have received the treatment over the 10 years it’s been in trial!
Upon release of the Phase 2 results in Jan. 2016, when my beloved was early stage, ALS orgs should’ve been doing everything possible to get NurOwn to patients immediately. Yet when I asked them, all I could get was excuses.
Thanks go to Mike Henson of No More Excuses for most of these and to Dr. Shah Mino for several of them.