INSTrUCT-SCI: INdependent Observational STUdy of Cell Tra... | NCT03069404

Studies
INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI

NCT03069404

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 15, 2020Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

Feb 9, 2017

First Submission Date that Met QC Criteria

Feb 27, 2017

First Posted Date

Mar 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2020

Last Update Posted Date

May 15, 2020Actual

Name	Class
Foundation Wings For Life	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.

Subjects will be monitored at routine intervals for safety and preliminary efficacy for 5 years post-transplantation of the Phase I/II investigation CL-N02-SC.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American Spinal Injury Association (ASIA) Impairment Scale Improvement	Evidence of improvement in ASIA impairment scale as confirmed by neurological examination	36 months after transplantation of HuCNS-SC®

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
Must be able to provide written informed consent prior to any study related procedures
Must agree to comply in good faith with all conditions of the study and to attend all required study visits
Female subjects who are pregnant remain eligible for enrollment, but the MRI examination will not be performed during the pregnancy. Female subjects of child-bearing potential must have a negative urine pregnancy test prior to the MRI examination

Exclusion Criteria:

Subjects have received or are receiving off-protocol immunosuppressive medications
Subjects who after completion of CL-N02-SC have entered, or are about to enter any other interventional study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Spinal cord injured patients T2-T11

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin Curt, MD	Universitätsklinik Balgrist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinik Balgrist		Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided