Actively Recruiting
Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
Led by S.Biomedics Co., Ltd. · Updated on 2025-05-18
5
Participants Needed
2
Research Sites
466 weeks
Total Duration
On this page
Sponsors
S
S.Biomedics Co., Ltd.
Lead Sponsor
L
Linical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study intends to evaluate the safety and exploratory efficacy of transplantation therapy using neural precursor cells (PSA-NCAM(+) NPC) derived from the human embryonic stem cell line for the treatment of paralysis and other related symptoms from sub-acute spinal cord injury.
CONDITIONS
Official Title
Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent from the patient or their legal representative
- Male and female patients aged 18 to 65 years
- Female patients must have a negative pregnancy test, use effective contraception, or have no possibility of pregnancy; male patients must have had vasectomy or use dual contraception for 90 days after treatment
- Patients able to receive the investigational product between 7 and 60 days after spinal cord injury
- Confirmed spinal cord injury classified as AIS-A by a specialist
- Injury located within spinal segments C4 to C7 with complete injury
You will not qualify if you...
- Spinal cord injury caused by penetrating trauma such as gunshot or stab wounds
- Complete transection of the spinal cord
- Spinal cord injury requiring treatment beyond one spinal segment
- Other neurological complications related to peripheral nerve injury or additional underlying conditions causing paraplegia or sensorimotor defects
- Multiple lesions or lesions longer than 2 cm on MRI
- Previous cell transfusion other than blood transfusion before the study
- Presence of coagulopathy with INR > 1.4 at treatment time
- Active infections
- Active hypotension needing vasoconstrictors (diastolic blood pressure below 60 mmHg)
- Skin rupture at the surgery site
- History of malignant tumors
- Primary or secondary immunodeficiency
- Significant abnormal laboratory values including elevated creatinine, liver enzymes, low hematocrit or hemoglobin, low white blood cell count, uncontrolled hypertension or diabetes, gastrointestinal bleeding, positive tuberculosis test without clear chest X-ray, hepatitis B or C, or HIV
- Substance abuse or alcoholism
- Untreated or unstable psychiatric disorders
- Known allergies to basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone, or prednisone
- Inability to receive physical or combination therapy
- Inability to undergo general anesthesia
- Investigator judgment deeming the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ajou University Hospital
Suwon, Gyeonggido, South Korea, 16499
Actively Recruiting
2
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
S
Sarang Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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