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Abstract Details

First-in-Man Report of Acute Intra-Arterial Allogeneic Mesenchymal Stem Cell Therapy in Two Patients with Locked-In Syndrome Post-Thrombectomy:
Cerebrovascular Disease and Interventional Neurology
P3 - Poster Session 3 (11:45 AM-12:45 PM)
14-007
NA

Complete Locked-in Syndrome (cLIS) from stroke is catastrophic, with <1% probability of significant motor recovery. In our pre-clinical canine model of reversible MCA stroke, we identified the maximum tolerated and effective dose of 40 million intra-arterial (IA) allogeneic mesenchymal stem cells (alMSCs).

 
Case 1: A 36-year-old man with basilar artery occlusion (BAO) and coma developed LIS despite successful EVT. Two doses of 20 million IA alMSCs (50% of the preclinical dose) were administered via the Penumbra 3 Max catheter into the proximal basilar artery at 4 and 14 days post-stroke.
Case 2: An 83-year-old man with BAO developed LIS after EVT. One dose of 20 million IA alMSCs was delivered at the vertebrobasilar junction at 6 days.
Case 1: No peri-procedural complications occurred. After the first dose, the patient experienced no neurological decline, though IL-6 levels spiked tenfold. MRI showed a 27cc reduction in infarct volume and NIHSS improved by 1 point, with new bilateral upper extremity withdrawal to pain. After the second dose and vertebral artery stenting, 4.5cc of new ischemia appeared on DWI, but without clinical worsening. At 6 months, the patient was off the ventilator and had improved facial, neck, and limb movement. At 27 months, he could follow commands, had silent verbalization, sat up, and self-fed with his right hand. NIHSS dropped from 27 to 9, mRS improved from 5 to 4, and MRI DTI showed marked improvement.
Case 2: No peri-procedural complications. Forty-eight hours post-treatment, DWI showed no new ischemia, but the NIHSS worsened by 7 points 4 days later due to fever and leucocytosis. Care was withdrawn on day 9.
This first-in-man report of IA alMSCs in two cLIS stroke patients demonstrated favorable safety and a signal of benefit in one case, supporting future clinical trials of IA MSCs for ischemic stroke.
Authors/Disclosures
Luis De Carvalho Paixao, MD
PRESENTER 		Dr. De Carvalho Paixao has nothing to disclose.
Dileep R. Yavagal, MD, FAAN (University of Miami Miller School of Medicine) Dr. Yavagal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vascular Dynamics. Dr. Yavagal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. The institution of Dr. Yavagal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GLG. Dr. Yavagal has received personal compensation in the range of $0-$499 for serving as a Consultant for Medtronic. Dr. Yavagal has received personal compensation in the range of $0-$499 for serving as a Consultant for Cerenovus/Johnson & Johnson. Dr. Yavagal has received personal compensation in the range of $0-$499 for serving as a Consultant for Stryker. Dr. Yavagal has received personal compensation in the range of $0-$499 for serving as a Consultant for Poseydon. Dr. Yavagal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Athersys. Dr. Yavagal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gravity Medical Technology. Dr. Yavagal has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Poseydon. Dr. Yavagal has stock in Poseydon. Dr. Yavagal has stock in Galaxy Therapeutics. Dr. Yavagal has stock in Stentrode. Dr. Yavagal has stock in Gravity Medical. Dr. Yavagal has stock in Gravity Medical Technology. Dr. Yavagal has stock in Athersys. Dr. Yavagal has stock in Rapid Medical . Dr. Yavagal has received intellectual property interests from a discovery or technology relating to health care. Dr. Yavagal has received personal compensation in the range of $5,000-$9,999 for serving as a Medicolegal Expert with Royal Carribean Cruise Line. Dr. Yavagal has received personal compensation in the range of $5,000-$9,999 for serving as a Medicolegal Consultant with Carnival Cruise Line.
Aaron E. Rodriguez-Calienes (University of Iowa Hospitals and Clinics) Dr. Rodriguez-Calienes has nothing to disclose.
Jude H. Charles, MD Dr. Charles has nothing to disclose.
Vasu Saini, MD Dr. Saini has nothing to disclose.
Roshni D. Thakkar, PhD (University of Miami) The institution of Dr. Thakkar has received research support from Applebaum Foundation.
Charif Sidani, MD Dr. Sidani has nothing to disclose.
Pradip Pattany, PhD Dr. Pattany has nothing to disclose.
Negar Asdaghi, MD (University of Miami) Dr. Asdaghi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Heart Association.
Aisha Khan Dr. Khan has received personal compensation for serving as an employee of University of Miami . Dr. Khan has stock in AssureImmun. Dr. Khan has stock in AX BIOTECH . Dr. Khan has stock in BIOLOGICS CONSULTING . The institution of Dr. Khan has received research support from NHLBI. The institution of Dr. Khan has received research support from NIH.