Ischemic and hemorrhagic stroke Circulatory System
Conditions
Interventions
For the retrospective chart review study, 50 patients with Sequelae of cerebrovascular hemorrhage and CVA (Stroke) Sequelae will be randomly selected from patients treated with hUCBSCs at the Wuhan Ho
two IV and one IT+IV administration
three IV administrations
three IT+IV administrations. The interval between administrations was 7-14 days. Selection of the treatment modality was based on the ability of the subject to tolerate IT injection. Subjects, unable
Sponsors
BHI Therapeutic Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. >18 years old 2. Diagnosis of ischemic stroke 3. Admitted to Wuhan Hongqiao Brain Hospital Co., Ltd between March 2009 and March 2012
Exclusion criteria
Exclusion criteria: 1. Incomplete records of subjects’ follow-up evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs), including vital signs and physical examination findings (baseline to 12 weeks post first intravenous/intrathecal administration) as assessed by adverse events questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in stroke assessment scales developed by Wuhan Hongqiao Brain Hospital (baseline to 12 weeks post first intravenous/intrathecal administration): 1. Upper extremity mobility 3/0 scale (3 = able to make a fist, eat independently, carry heavy weights and realize normal activities; 0 = high muscle tension, not able to bend independently, eat and realize other normal activities) 2. Lower extremity mobility 3/0 scale (3 = able to walk with or without help; 0 = high muscle tension, not able to move independently, stay and walk) 3. Neurological function (ability to speak) was graded on a 5/0 scale (5 = conscious, able to speak clearly; 0 = deep coma/mild coma/light coma-like/unconscious, unable to open eyes and speak) 4. Upper and lower extremity muscle strength 5/0 scale (5 = normal motor function; 0 = total paralysis) 5. Neurological function (urination) 1/0 scale (1 = urinates via a catheter; 0 = urine incontinence) 6. Neurological function (bowel function) 1/0 scale (1 = normal bowel function; 0 = stool incontinence) | — |
Countries
China
Outcome results
None listed