Retrospective chart review study of umbilical cord stem cell therapy for stroke
| ISRCTN | ISRCTN10678357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10678357 |
| Secondary identifying numbers | 00110 |
- Submission date
- 14/06/2019
- Registration date
- 09/07/2019
- Last edited
- 15/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Stroke is a leading cause of adult disability worldwide and the second highest cause of death in the world. To date, there are no clinically effective pharmacotherapies that can promote or facilitate cellular functional recovery after an ischemic stroke. Human umbilical cord blood cell therapy is a promising treatment for ischemic stroke. The current retrospective chart review study is aimed to analyze the impact of human umbilical cord blood mononuclear cell therapy on mobility and muscle strength of upper and lower extremities, and neurological function in subjects with ischemic and hemorrhagic stroke.
Who can participate?
Adult subjects with ischemic and hemorrhagic stroke who were treated with human umbilical cord blood mononuclear cells in the Wuhan Hongqiao Brain Hospital Co., Ltd. (Wuhan, Hubei) between March 2009 and March 2012, were included in the study.
What does the study involve?
Fifty patients with Sequelae of cerebrovascular hemorrhage and CVA (Stroke) Sequelae will be randomly selected from 96 patients treated with hUCBSCs at the Wuhan Hongqiao Brain Hospital Co., Ltd. (Wuhan, Hubei) between March 2009 and March 2012. Another fifty patients with stroke, who received only traditional therapy and no stem cell therapy, will be included as the control group. Data collection will include: base-line characteristics of research subjects, adverse events specification after therapy, physical examination results pre- and post-therapy, including mobility of upper and lower extremities, neurological function, and muscle strength of upper and lower limbs. Data analysis will include analysis of mobility, muscle strength of upper and lower extremities and neurological function pre- and post-therapy in stem cell and conventional therapy group; correlation between initiation of stem cell treatment and effectivity of treatment; correlation
between stem cell infusion/injection strategy and effectivity of treatment.
What are the possible benefits and risks of participating?
Possible benefits: improvement of post-stroke symptoms, particularly the improvement of mobility and muscle strength of upper and lower extremities, and neurological function. hUCMNC therapy could ameliorate one’s symptoms to a certain extent; however potential curative effects will differ based on individual characteristics. Some subjects could be totally back to their normal lives.
Possible risks: approximately 1% of subjects experience a low-grade fever, headache or post-transplantation excitation all of which, generally, spontaneously remit in 24 to 48 hours.
Where is the study run from?
1. BHI Therapeutic Sciences (214 State Street, Hackensack, NJ, USA)
2. Wuhan Hongqiao Brain Hospital Co., Ltd (Wuhan, China)
When is the study starting and how long is it expected to run for?
January 2017 - February 2019
Who is funding the study?
BHI Therapeutic Sciences
Who is the main contact?
Dr Marine Manvelyan,
mmanvelyan@bluehorizoninternational.com
Contact information
Scientific
214 State Street Ste 101
Hackensack
07601
United States of America
 ORCID ID |
0000-0002-8202-0341 |
|---|---|
| Phone | 2013427662 |
| mmanvelyan@bluehorizoninternational.com |
Study information
| Study design | Case-control retrospective analysis |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Retrospective chart review study of Umbilical Cord Blood Stem Cell (UCBSC) transplantation for sequelae of CVA (Cerebral Vascular Accident, Stroke) |
| Study hypothesis | The study aimed to analyze the impact of human umbilical cord blood mononuclear cell therapy on mobility and muscle strength of upper and lower extremities, and neurological function in subjects with ischemic and hemorrhagic stroke |
| Ethics approval(s) | The retrospective chart review study was approved 03/02/2017, Institute of Regenerative and Cellular Medicine Institutional Review Board (1301 20th St., Suite #530, Santa Monica, CA 90404, USA; +1(888) 664-8893; jpfaber@ircm.org), ref: IRCM-2017-135 The study in which the original data was collected was approved 30/06/2009, Ethics Committee of Wuhan Hongqiao Brain Hospital (Jiang'an District, Wuhan Development Avenue No. 387-393, Wuhan, China, 430071; 86-18207143738; bcdcwu@hotmail.com), ref: HQNK-2009-0630 |
| Condition | Ischemic and hemorrhagic stroke |
| Intervention | 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 Hongqiao Brain Hospital Co., Ltd. (Wuhan, Hubei) between March 2009 and March 2012. Another 50 patients with stroke, who received only traditional therapy and no stem cell therapy, will be included as the control group. 97 subjects with ischemic and hemorrhagic stroke, treated with human umbilical cord blood mononuclear cells in the Wuhan Hongqiao Brain Hospital Co., Ltd. (Wuhan, Hubei) between March 2009 and March 2012. Subjects received three administrations of 5 ml human umbilical cord blood mononuclear cells (3×10^8) isolated from human umbilical cord blood of three different donors. Treatment was conducted in three sessions that included intrathecal (IT), intravenous (IV) and the combination of IT plus IV (IT+IV) administrations. Different treatment modalities were applied to subjects: one IV and two IT+IV administrations; 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 to tolerate IT injection, received three IV or one IT+IV plus two IV administrations. Chart records are located at the Wuhan Hongqiao Brain Hospital Co., Ltd. (Wuhan, Hubei) and BHI Therapeutic Sciences (214 State Street, Hackensack, NJ 07601). Charts were reviewed, and information regarding subjects’ demographics, cell therapy modality and stroke assessment scales results (baseline and 12 weeks post-therapy) were collected in the data collection forms. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Human umbilical cord blood mononuclear cells (hUCBMNCs) |
| Primary outcome measure | 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 outcome measures | 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) |
| Overall study start date | 03/02/2017 |
| Overall study end date | 12/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 97 |
| Total final enrolment | 97 |
| Participant 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 |
| Participant exclusion criteria | 1. Incomplete records of subjects’ follow-up evaluation |
| Recruitment start date | 06/02/2017 |
| Recruitment end date | 01/12/2018 |
Locations
Countries of recruitment
- China
- United States of America
Study participating centres
Wuhan Development Avenue
No. 387-393
Wuhan
430071
China
Hackensack
07601
United States of America
Sponsor information
Research organisation
214 State Street Ste 101
Hackensack
07601
United States of America
| Phone | 2013427662 |
|---|---|
| mmanvelyan@bluehorizoninternational.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 11/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 18/01/2017 | 11/07/2019 | No | No |
Additional files
- ISRCTN10678357_Protocol_18Jan2017.pdf
- Uploaded 11/07/2019
Editorial Notes
15/07/2020: The overall end date was changed from 12/01/2020 to 12/12/2020.
08/01/2020: The following changes have been made:
1. The overall trial end date has been changed from 11/01/2019 to 12/01/2020.
2. The intention to publish date has been changed from 09/01/2019 to 11/01/2020.
11/07/2019: Protocol file uploaded (not peer-reviewed).
02/07/2019: Trial’s existence confirmed by Institute of Regenerative and Cellular Medicine Institutional Review Board
