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StroKE34 Study Protocol: a randomized Controlled Phase IIa trial of intra-arterial Cd34+ Cells in acute ischemic Stroke

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520850-13-00
Acronym
2017-002456-88
Enrollment
30
Registered
2025-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief summary

Infarct volume at three months after ischemic stroke, Volume de enfarte aos três meses após AVC isquémico

Detailed description

Functional outcome: modified Rankin Scale (mRS), Stroke Impact Scale (SIS), Cognitive performance: Montreal Cognitive Assessment scale (MoCA), Functional Independence and performance : Barthel Scale; Upper limb Capacity - Stroke Upper Limb Capacity Scale – SULCS; Evaluation of gait speed (TEST 10 METERS); Evaluation of temporospacial gait (GAIT RIte speed), Depression - Hospital Anxiety and Depression Scale- (HADS Scale), Qualitiy of life assessment - EuroQol Scale( EQ-5D), Deglutition: Teste Rápido de Identificação da Disfagia (TRIDIS); Functional Oral Intake de Identificação da Disfagia (FOIS), Aphasia: Bateria de Avaliação de Afasia de Lisboa - BAAL; The Aphasia Rapid Test (ART)

Interventions

DRUGStrimvelis 1-10 x 106 cells/mL dispersion for infusion

Sponsors

Unidade Local De Saude De Coimbra E.P.E.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Infarct volume at three months after ischemic stroke, Volume de enfarte aos três meses após AVC isquémico

Secondary

MeasureTime frame
Functional outcome: modified Rankin Scale (mRS), Stroke Impact Scale (SIS), Cognitive performance: Montreal Cognitive Assessment scale (MoCA), Functional Independence and performance : Barthel Scale; Upper limb Capacity - Stroke Upper Limb Capacity Scale – SULCS; Evaluation of gait speed (TEST 10 METERS); Evaluation of temporospacial gait (GAIT RIte speed), Depression - Hospital Anxiety and Depression Scale- (HADS Scale), Qualitiy of life assessment - EuroQol Scale( EQ-5D), Deglutition: Teste Rápido de Identificação da Disfagia (TRIDIS); Functional Oral Intake de Identificação da Disfagia (FOIS), Aphasia: Bateria de Avaliação de Afasia de Lisboa - BAAL; The Aphasia Rapid Test (ART)

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026