'Stem cell Trial of recovery EnhanceMent after Stroke 3’ (STEMS 3)- a pilot randomised controlled trial of G-CSF and therapy in chronic stroke - Stem cell Trial of recovery EnhanceMent after Stroke 3 (STEMS 3)

Phase 1

• Conditions: Stroke with residual deficit

• Registration Number: EUCTR2011-001684-50-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-15
• Study Completion: 2013-10-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Adults (18 years and over) with motor impairment (arm or leg) with residual disability (modified Rankin Score >1) due to stroke >90 days post onset.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lack of residual motor deficit; significant cognitive impairment that will impede ability to complete assessments, diagnosis likely to interfere with outcome or rehabilitation (e.g. terminal illness), still receiving post stroke rehabilitation; pregnancy; other exclusions of G-CSF (as per British National Formulary –see SmPC).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety, feasibility, and tolerability of delivering the drug G-CSF and or rehabilitation therapy in chronic stroke patients.;Secondary Objective: 1) To study potential interaction between the drug G-CSF and rehabilitation therapy in chronic stroke patients. 2) Finalise the design including the sample size calculations and outcome measures for the definitive trial, by obtaining information on functional measures, the spectrum of disability among trial recruits and the completeness of outcome data.;Primary end point(s): Feasibility: proportion of participants receiving all 5 G-CSF/placebo injections; proportion of participants receiving all therapy sessions. Acceptability- proportion of participants screened who are eligible for enrollment who give consent; Tolerability- Adverse events (headache, backache) reported after G-CSF adminisitration; proportion of participants who withdraw or decline rehabiliation therapy sessions.