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Pilot Investigation of Stem Cells in Stroke Phase II Efficacy

NCT02117635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-07-23

No results posted yet for this study

Summary

The primary aim of this Phase II trial is to determine whether it is sufficiently likely that CTX DP treatment at a dose level of 20 million cells improves the recovery in the use of the paretic arm in acute stroke patients to justify a subsequent larger prospectively controlled study.

This study will evaluate the safety and efficacy of intracerebral CTX DP at a dose level of 20 million cells in patients with paresis of an arm following an ischaemic middle cerebral artery (MCA) stoke. Eligible patients will have no useful function of the paretic arm a minimum of 28 days after the ischaemic stroke (a modified NIH Stroke Scale (NIHSS) Motor Arm Score of 2, 3 or 4 for the affected arm).

Conditions

  • Ischaemic Stroke
  • Cerebral Infarction
  • Hemiparesis
  • Arm Paralysis

Interventions

BIOLOGICAL

CTX DP

20 million cell dose administered by surgery to the damaged area of the brain

Sponsors & Collaborators

  • ReNeuron Limited

    lead INDUSTRY

Principal Investigators

  • Keith W Muir · University of Glasgow

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-10-31
Completion
2017-08-16

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117635 on ClinicalTrials.gov