Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebral Palsy | Biological: ASTROSTEM | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP) |
Actual Study Start Date : | June 15, 2017 |
Actual Primary Completion Date : | April 23, 2019 |
Actual Study Completion Date : | May 13, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Astrostem
Autologous Adipose Tissue Derived Mesenchymal Stem Cells
|
Biological: ASTROSTEM
Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg ~ 25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL
Other Name: Autologous Adipose Tissue Derived Mesenchymal Stem Cells
|
Ages Eligible for Study: | 36 Months to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
KyungHee University Gandong Hospital | |
Seoul, Korea, Republic of |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | August 1, 2016 | ||||
First Posted Date ICMJE | June 7, 2019 | ||||
Last Update Posted Date | June 7, 2019 | ||||
Actual Study Start Date ICMJE | June 15, 2017 | ||||
Actual Primary Completion Date | April 23, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Kaufman Assessment Battery for Children (K-ABC) [ Time Frame: Baseline and 12 month ] Change from Baseline K-ABC at 12 months
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP | ||||
Official Title ICMJE | Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP) | ||||
Brief Summary | Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP | ||||
Detailed Description | The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP) | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Early Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Cerebral Palsy | ||||
Intervention ICMJE | Biological: ASTROSTEM
Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg ~ 25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL
Other Name: Autologous Adipose Tissue Derived Mesenchymal Stem Cells
|
||||
Study Arms ICMJE | Experimental: Astrostem
Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Intervention: Biological: ASTROSTEM
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
1 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | May 13, 2019 | ||||
Actual Primary Completion Date | April 23, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 36 Months to 12 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03979898 | ||||
Other Study ID Numbers ICMJE | biostar-CP | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | R-Bio | ||||
Study Sponsor ICMJE | R-Bio | ||||
Collaborators ICMJE | Kyung Hee University Hospital at Gangdong | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | R-Bio | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |