New implant could help SMA patients who Can't get spinal injections

NCT ID NCT05866419

Recruiting now Disease control Sponsor: Alcyone Therapeutics, Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a new implantable device called ThecaFlex DRx in 90 people with spinal muscular atrophy (SMA) who cannot receive standard spinal injections due to spine problems or other risks. The device is placed under the skin and delivers the medication nusinersen directly into the spinal fluid. Researchers will check if the device works safely and effectively over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ThecaFlex DRx System (implantable port and catheter)
What this could lead to: If successful, this device could provide a safer, easier way to deliver life-saving SMA medication to patients who currently cannot receive it due to spine problems.
What could go wrong: This is an early feasibility study with no control group, so results may not confirm the device is better than standard care. Implant surgery carries risks like infection or device malfunction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

scoliosis spinal muscular atrophy vertebral column disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCOLIOSIS SPINAL MUSCULAR ATROPHY SPINE DEFORMITY

Contacts and locations

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Locations

Barrow Neurological Institute
RECRUITING

Phoenix, Arizona, 85013, United States
Boston Children's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Children's Hospital Orange County
RECRUITING

Orange, California, 92868, United States
Children's Hospital Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Childrens Hospital of the King's Daughters
RECRUITING

Norfolk, Virginia, 23510, United States
Columbia University Irving Medical Center/NewYork Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Helen DeVos Children's Hospital
RECRUITING

Grand Rapids, Michigan, 49503, United States
Hospital Universitario La Paz
RECRUITING

Madrid, Spain
Hospital Universitario y Politecnico la Fe de Valencia
RECRUITING

Valencia, 46026, Spain
Lurie Childrens Hospital
RECRUITING

Chicago, Illinois, 60611, United States
Nemours Children's Hospital, Florida
RECRUITING

Orlando, Florida, 32827, United States
Penn State Milton S. Hershey Medical Center
RECRUITING

Hershey, Pennsylvania, 17033, United States
Rady Children's Hospital
RECRUITING

San Diego, California, 92037, United States
Research Institute of Polish Mother's Memorial Hospital
RECRUITING

Lodz, Poland
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING

Sheffield, United Kingdom
Specialised Hospital Ludwika Rydygiera
RECRUITING

Krakow, Poland
Stanford Medical Center
RECRUITING

Palo Alto, California, 94301, United States

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Texas Children's Hospital
RECRUITING

Houston, Texas, 77030, United States
UH Rainbow Babies and Children's Hospital
RECRUITING

Cleveland, Ohio, 44106, United States
University of Virginia
RECRUITING

Charlottesville, Virginia, 22903, United States
Universitätsklinikum Essen
RECRUITING

Essen, Germany

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