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An early-stage clinical trial evaluating CK0803, <a href="https://cellenkosinc.com/">Cellenkos</a>&#8216; regulatory T-cell-based therapy for people with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS), has completed dosing its first patient group, the company announced in a <a href="https://www.prnewswire.com/news-releases/michael-e-debakey-va-medical-center-va-hospital-announces-new-cell-therapy-clinical-trial-for-amyotrophic-lateral-sclerosis-302039441.html">press release</a>.
The six patients, all adults, were treated at the Columbia University Irving Medical Center, in New York City, in the Phase 1 run-in period of the <a href="https://clinicaltrials.gov/ct2/show/NCT05695521">REGALS Phase 1/1b clinical trial (NCT05695521)</a>, which focused on safety. The trial now will enroll another 60 adults with ALS in its randomized Phase 1b part to continue to examine the treatment’s safety and efficacy.
The participants to date have been recruited at the single New York study site, but a U.S. Department of Veteran Affairs (VA) hospital in Houston has <a href="https://www.va.gov/houston-health-care/stories/new-hope-for-als-veterans/#:~:text=DeBakey%20VA%20Medical%20Center%20in,treatment%20for%20the%20neurodegenerative%20disease.">announced it will recruit 10 patients</a> for the clinical trial, slated to span about six months.
The Michael E. DeBakey Veteran Affairs Medical Center is the first and only VA hospital in the U.S. to join REGALS — and provide military veterans the opportunity to receive the cell-based therapy, which is designed to reduce neuroinflammation and balance the activity of the immune system.
&#8220;We are thrilled that our veterans will get the opportunity to receive such a cutting edge therapeutic that could be life altering,&#8221; said James Orengo, MD, PhD, principal investigator of the study at the DeBakey VA Medical Center.
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<h3>VA hospital &#8216;excited&#8217; to be among first sites to test novel therapy</h3>
&#8220;The incidence of ALS is elevated in veterans and novel therapies are desperately needed,&#8221; Orengo said.
Indeed, it&#8217;s estimated that more than 16% of all ALS patients are veterans, who are <a href="https://alsnewstoday.com/causes-of-als/">twice as likely to develop the disease</a> as are individuals in the general population.
Scientists have suggested that this increased prevalence likely is related to increased exposure to chemicals, strenuous physical conditions, and trauma during military service.
&#8220;We made a conscious decision to make this novel cell therapy available to the veterans and remain committed to provide our continued support to those who have served our country,&#8221; said Tara Sadeghi, Cellenkos&#8217; chief operating officer, noting that &#8220;there is an urgent need for novel treatments for all forms of ALS.&#8221;
Altogether, the REGALS trial will involve a total of 66 ALS patients with disease onset in the previous five years. All will receive the cell-based therapy through intravenous or into-the-vein infusions. The first four treatment doses are given weekly, followed by monthly infusions for the next five months.
[quote=&#8221;center&#8221;]We made a conscious decision to make this novel cell therapy available to the veterans and remain committed to provide our continued support to those who have served our country.[/quote]
In the <a href="https://alsnewstoday.com/news/patient-dosed-trial-potential-als-cell-based-therapy-ck0803/">Phase 1 part of the trial</a>, which is now complete, researchers assessed the treatment&#8217;s safety and efficacy. The main goals of the Phase 1b part are to determine the incidence and severity of side effects as well as changes in a combined assessment of function and survival.
Secondary efficacy measures include changes in the rate of disease progression, quality of life, lung function, and muscle strength.
For its part, the Houston VA clinic is &#8220;excited to be one of the first sites [to test this] novel T regulatory cells therapy for ALS,&#8221; Barbara W. Trautner, the center&#8217;s deputy associate chief of staff for clinical research, said in the VA announcement.
&#8220;We hope this is the first of many trials that we can open to develop new therapies for veterans with neurodegenerative disorders,” Trautner said, noting that the center&#8217;s neurologists &#8220;jumped at the chance to offer this to our veterans.&#8221;
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<h3>Cell-based therapy aims to reduce inflammation in ALS</h3>
People with ALS generally have high levels of inflammatory T-cells, which aid in the progressive dysfunction and death of motor neurons, the nerve cells that control voluntary movements. Conversely, immunosuppressive regulatory T-cells, known as Tregs, usually are found at lower levels than are normal in these patients, and are also less effective.
Tregs are immune cells that help suppress excessive inflammation and maintain the immune system&#8217;s healthy functioning. As such, they&#8217;re believed to help reduce some of the inflammation that causes damage in ALS.
CK0803 is a cell-based therapy that uses Tregs isolated from healthy umbilical cord blood, without the need to match patient and donor. These cells are then enriched and differentiated to target a given condition using the company&#8217;s proprietary <a href="https://cellenkosinc.com/ourscience/index.html">CRANE technology</a>.
The technology enables the production of several CK0803 doses from a single umbilical cord blood unit, and the final product can be frozen and stored for long periods — making treatments readily available for patients when needed.
“We are very excited to open this first cell therapy trial for ALS in the VA,” Orengo, also a professor of neurology at Baylor College of Medicine, in Houston, said in the Veteran Affairs announcement.
“We know that neuroinflammation fuels the ALS disease process. We believe that this new treatment, which involves calming the immune system in the central nervous system, holds great promise in halting this disease,” Orengo said.

Trial of cell-based therapy CK08031 finishes dosing 1st patient group

Did you know that more than 16% of <a href="https://alsnewstoday.com/what-is-als/">ALS</a> patients have <a href="https://valorhealthcare.com/what-percentage-of-als-patients-are-veterans/#:~:text=More%20than%2016%25%20of%20patients,increased%20risk%20of%2C%20including%20ALS.">served in the military</a>? Are you aware that veterans are <a href="https://alsnewstoday.com/social-clips/veterans-twice-likely-develop-als/">twice as likely to develop ALS</a> as those who haven&#8217;t been in the military?
If not staggering, those facts are compelling. Many theories have been put forth regarding the relationship between people with ALS and military service, but nothing is conclusive. The most prevalent theory seems to be exposure to toxins.
Since we don&#8217;t know the <a href="https://alsnewstoday.com/causes-of-als/">cause</a> or cure for ALS, the next best thing is how we <a href="https://alsnewstoday.com/columns/early-intervention-key-early-detection-als/">respond to it</a>. While I believe researchers and other health professionals are doing everything they can to uncover answers, I have a personal perspective on response.
The <a href="https://www.va.gov/">U.S. Department of Veterans Affairs</a> (VA) has responded excellently to me and my family. Ever since my daughter contacted the <a href="https://www.dav.org/">Disabled American Veterans</a> (DAV) nonprofit in Columbia, South Carolina, in 2014, I&#8217;ve been bragging about both organizations.
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The DAV counseled me and gave me a list of every piece of documentation I needed to send to them. I complied, and they took it from there, contacting the VA and an <a href="https://www.als.org/local-support/certified-centers-clinics">ALS clinic</a> in Charleston, South Carolina, to set up my initial consultation.
The DAV also submitted and followed up on my benefits application, and less than 90 days later I was in the VA system, which included monthly visits to the ALS clinic at the Ralph H. Johnson VA Medical Center in Charleston. Since then, I&#8217;ve been treated by some of the best people I&#8217;ve ever known.
My VA team has truly been my family&#8217;s saving grace and our guardian angels. They have provided equipment, prosthetic devices, <a href="https://alsnewstoday.com/approved-treatments-for-als/">medicines</a>, respite breaks, and a host of other services. We now have quarterly telehealth Zoom calls with them, which are convenient for me in light of my traveling constraints.
It&#8217;s not just their expertise and dedication that are important to me; it&#8217;s their <a href="https://alsnewstoday.com/columns/tips-als-caregivers-hospital-setting/">kindness and genuineness</a>, which are obvious to me and have been displayed for nine years now. I can&#8217;t speak for other VA systems, but the South Carolina system is great, and I wouldn&#8217;t trade it for any other.
We live in an era where bashing the VA is fairly widespread, and some of it&#8217;s justified, I&#8217;m sure. But based on my personal experience, albeit relatively small, the VA has been outstanding. I appreciate the staff members who attend to my needs, and I&#8217;ll always laud their service and basic humanity when it comes to responding to my ALS.
I recognize that many ALS patients don&#8217;t have the VA to lean on. I can and often do imagine what it&#8217;s like to be without various equipment and supplies that mitigate the ravages of this horrible disease. That reality, however, must not prevent us from giving credit when and where it&#8217;s due.
Here&#8217;s a thought: When it comes to ALS, the VA could <a href="https://alsnewstoday.com/columns/tips-als-caregivers-outpost-respite-care/">teach other providers</a> a thing or two. So why not have the VA share what they know about caring for ALS patients with insurance providers? Maybe it&#8217;d make providers a little more flexible when assessing and approving services for their clients.
I know services are expensive, but isn&#8217;t it worth more money to provide a modicum of comfort to another human being? After all, anyone can develop ALS, not just veterans.
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Note: <a href="https://alsnewstoday.com/">ALS News Today</a> is strictly a news and information website about the disease. It does not provide medical advice, <a href="https://alsnewstoday.com/als-diagnosis/">diagnosis</a>, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of ALS News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to ALS.

Tag: veterans with ALS

Trial of cell-based therapy CK08031 finishes dosing 1st patient group

How veterans organizations helped me respond to ALS