Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769872
• Other study ID #: KSC-MSCs-SPI
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 15, 2013
• Last updated: August 1, 2016
• Start date: January 2013

Study information

• Verified date: August 2016
• Source: Biostar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 spinal cord injury

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects who understand and sign the consent form for this study

• Age : 19-70

• Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)

• Duration of injury : > 3 month

Exclusion Criteria:

• Subjects who must put on a respirator

• Subjects who had malignant tumor within 5 years

• Subjects with a infectious disease include HIV and hepatitis

• Subjects who injured brain or spinal cord before spinal cord injury

• Subjects with anemia or thrombocytopenia

• Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease

• Subjects with congenital or acquired immunodeficiency disorders

• Patients with clouded consciousness or speech disorder

• treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials

• participating another clinical trials within 3 months

• other serious disease or disorder that could seriously affect ability to participate in the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Procedure:
• Autologous Adipose Tissue derived MSCs Transplantation
Intravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Biostar	Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASIA (American Spinal Injury Association) scale	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.	32 weeks	No
Secondary	Magnetic Resonance Imaging	To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs.	32 weeks	No
Secondary	MEP/SSEP	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.	32 weeks	No
Secondary	ADL (activities of daily living)	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.	32 weeks	No
Secondary	SF-36	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.	32 weeks	No
Secondary	ODI (Oswestry Disability Questionnaire)	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.	32 weeks	No
Secondary	Frequency of Adverse Events		32 weeks	Yes