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Retrospective chart review study of umbilical cord stem cell therapy for stroke

Retrospective chart review study of Umbilical Cord Blood Stem Cell (UCBSC) transplantation for sequelae of CVA (Cerebral Vascular Accident, Stroke)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10678357
Enrollment
97
Registered
2019-07-09
Start date
2017-02-06
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Ischemic and hemorrhagic stroke Circulatory System

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
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026