Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care

NATerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 21, 2019

Primary Completion Date

March 9, 2023

Study Completion Date

December 31, 2023

Conditions
Injury, Spinal Cord
Interventions
DEVICE

Neuro-Spinal Scaffold

"The investigational product (Neuro-Spinal ScaffoldTM or Scaffold) is a porous bioresorbable polymer scaffold comprised of a synthetic biomaterial, poly(lactic-co-glycolic acid)-b-poly(L-lysine) (PLGA-PLL). The Scaffold is cylindrical in shape (3 mm diameter) and is available is three lengths (6 mm, 8 mm, 10 mm) for optimal fit in the intraspinal lesion cavity.~Based upon pre-clinical testing, the Scaffold is expected to be resorbed from the site of implant within 4 to 8 weeks."

Trial Locations (16)

10003

Icahn School of Medicine at Mount Sinai, New York

11373

Elmhurst Hospital Center, Elmhurst

15213

University of Pittsburgh Medical Center-Presbyterian, Pittsburgh

19104

Penn Presbyterian Medical Center, Philadelphia

19107

Thomas Jefferson University, Philadelphia

21201

University of Maryland Medical Center, Baltimore

27834

Vidant Medical Center, Greenville

33613

University of South Florida Health Neurosurgery, Tampa

52242

University of Iowa, Iowa City

53226

Medical College of Wisconsin, Milwaukee

78229

University of Texas Health San Antonio, San Antonio

80909

University of Colorado Memorial Hospital Central, Colorado Springs

92103

University of California San Diego, San Diego

95817

UC Davis Medical Center, Sacramento

07101

Rutgers Center for Spine Surgery, Newark

02903

Rhode Island Hospital, Providence

Sponsors
All Listed Sponsors
lead

InVivo Therapeutics

INDUSTRY

NCT03762655 - Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care | Biotech Hunter | Biotech Hunter