FDA has approved an aggressive stem cell clinical trial, offering potential new relief through intravenous (IV) administration.
HENDERSON, Nev., May 13, 2025 /PRNewswire-PRWeb/ -- "We at L2 Bio thank the FDA for what we believe is a very aggressive approval in the fight against Crohn's Disease," states Vince Liguori, CEO of L2 Bio, LLC.
The FDA approval Is for a 120-person, multi-site, double-blind, randomized, placebo-controlled Phase IIb clinical trial to evaluate the safety and efficacy of L2-01 AD-MSCs in subjects with Crohn's Disease, with stem cells administered intravenously (IV). One of the reasons this approval is so significant is that the physician principal investigator (PI) will be able to determine if the subject can remain on current medications that may be offering some positive outcomes, as opposed to having the subject stop the use of all medications, which is more typical in a clinical trial. This is a strong positive reinforcement from the FDA in support of one of L2 Bio's core beliefs: that the "physician-patient relationship" and the doctor's right to "clinical autonomy" is the basis of good medicine.
The guiding principle of the Hippocratic Oath, "first, do no harm," is often overlooked in modern medicine. Utilizing autologous or a first-degree blood relative donor to grow stem cells drastically improves the safety profile of this procedure and affords L2 Bio the potential to grow enough stem cells to treat a patient for life from just about two tablespoons of fat. "L2 Bio firmly believes that if a drug has the potential to help the person with little or no contraindications, it should always be explored first. And that's the position we want L2 to take in the fight against Crohn's, Inflammatory Bowel Disease (IBD) and many other autoimmune disorders: first, do no harm, and to be utilized as the first option because of what we believe L2-01 offers is the highest safety profile in medicine," said Vince Liguori, CEO of L2 Bio, LLC.
Accredited Investors: Join L2 Bio in pioneering the future of Crohn's Disease treatment! As we advance our aggressive stem cell clinical trial (IV delivery), we're seeking secondary investment to fuel this giant leap forward. Contact Investor Relations: [email protected]
Media Contact
Gabe Solis, L2 Bio, LLC, 1 702 723 0235, [email protected], WWW.L2Bio.com
Gabriel Solis, L2 Bio, LLC, 1 702 723 0235, [email protected], www.L2Bio.com
SOURCE L2 Bio, LLC
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