InVivo enrolls 5th spinal cord injury patient in trial: 5 things to know

Spinal Tech

InVivo Therapeutics enrolled the fifth patient in their investigational Neuro-Spinal Scaffold clinical trial.

Here are five things to know about the procedure:

 

1. The fifth patient enrolled in the trial — which examines the Neuro-Spinal Scaffold implant for patients with acute thoracic spinal cord injury — was enrolled at Keck Hospital at the University of Southern California in Los Angeles. This is the first patient at USC in the trial, which has multiple sites across the country.

 

2. The patient was treated around 69 hours after injury. Of the first three patients treated, two are showing improvement.

 

3. Patrick Hsieh, MD, is the principal investigator at the USC site.

 

4. InVivo hopes to use the outcomes from this study to achieve the Humanitarian Device Exemption, which reduces the time to approve a new treatment and bring the device to market. The company is discussing plans with the FDA for a probable benefit study and incorporating the pilot study to expand the number of patients enrolled beyond five.

 

"We anticipate that we will receive formal approval of this expansion within the next two months. During this interim period, additional eligible patients at participating clinical sites may receive the Neuro-Spinal Scaffold under the Emergency Use Expanded Access Mechanism, on a case-by-case basis, and the safety and outcomes data of these patients will be included in the HDE application," said InVivo CEO and Chairman Mark Perrin.

 

5. Mr. Perrin is optimistic about finalizing the probable benefit study design in the coming months. The Neuro-Spinal Scaffold is for patients with complete (AIS A) traumatic acute spinal cord injury.

 

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