KCT0007731
Not yet recruiting
未知
A study to evaluate the safety of transplantation therapy using microspheroids assembled by peripheral nerve-derived adult stem cells in acute,sub-acute spinal cord injury patients
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Injury, poisoning and certain other consequences of external causes
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 6
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Patient or substitute agreed with written consent
- •2\)Patients with more than 19 years old
- •3\)Female patients with negative in pregnancy test, acceptable contraceptive method, being not possible of pregnancy (more than 2 years after menopause, history of hysterectomy, oophorectomy, or sterilization operation) or male patients who underwent vasectomy or are willing to do double block contraceptive method\* until 90 days post\-administration.
- •\*Double block contraceptive method : complex contraceptive method such as male condom combined with cervix cap or contraceptive diaphragm
- •4\) Patients who are able to get clinical trial of medication at 180 days post\-spinal cord injury
- •5\) Patients with spinal cord injury was confirmed as ASIA\-A to C with ISNCSCI, SCIM and/or MRI by experimenter, physiatrist, or other specialist in spinal cord injury
- •6\) Patients who meet ASIA criterion
- •a. Group A : complete spinal cord injury at C4\-C7 level, ASIA\-A
- •b. Group C : preserved some motor and sensory function, incomplete spinal cord injury at C4\-C7 level, ASIA C, lower extremity total motor score less than 25
Exclusion Criteria
- •1\)Spinal cord injury caused by penetrating injuries such as gunshot or stab wound
- •2\)Spinal cord injury with complete cord transection
- •3\)Spinal cord injury including long segments
- •4\)Patients with peripheral nerve injury (neuromuscular injury, central cord syndrome)\-related nervous system damage or underlying disease related paraplegia or sensorimotor defect
- •5\)On MRI, lesion confirmed of multiple segmental or more than 2cm
- •6\)Spinal cord injury patient diagnosed with ASIA D on ISNCSSCI, SCIM or MRI
- •7\)Patients who administered cell therapy except transfusion before clinical trial drug
- •8\)Patients who have diseases or conditions followed as
- •a.Coagulopathy (INR \>1\.4\) at administration of clinical trial drug (Day 0\)
- •b.Active infection
Outcomes
Primary Outcomes
Not specified
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