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Tests treatment safety and results for Spinal Cord Injury, Acute
Official title Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
ClinicalTrials.gov ID: NCT04812431
What this study is testing
What is Neural precursor cells derived from human embryonic stem cell line?
Neural precursor cells derived from human embryonic stem cell line is an investigational medicine, being studied as a potential treatment for spinal cord injury, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Upon written consent of the patient or the legally acceptable representative of the patient
- Male and female patients 18 to 65 years of age
- Female patients who showed negative results on the pregnancy test, use an acceptable contraceptive or have no possibility of pregnancy (at least 2...
- Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury
- Patients who have been confirmed to have spinal cord injury classified as AIS-A on ISNCSCI, SCIM and/or MRI by the investigator, physiatrist, or...
You likely can't join if
- Patients with spinal cord injury caused by penetrating trauma such as gunshot or stab wounds
- Patients with complete transection on the spinal cord
- Patients with spinal cord injury that require more than the mono-segment treatment
- Patients with other complications, including neurological defects related to peripheral nerve injury (neuromuscular injury or central spinal cord...
- Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination
- Patients administered with cells excluding blood transfusion before participating in the clinical study
See the full eligibility criteria
- Upon written consent of the patient or the legally acceptable representative of the patient
- Male and female patients 18 to 65 years of age
- Female patients who showed negative results on the pregnancy test, use an acceptable contraceptive or have no possibility of pregnancy (at least 2 years have elapsed after menopause or have undergone hysterectomy...
- Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury
- Patients who have been confirmed to have spinal cord injury classified as AIS-A on ISNCSCI, SCIM and/or MRI by the investigator, physiatrist, or other spinal cord injury specialist
- Patients whose ASIA Impairment Scale (AIS) satisfies AIS-A criteria (spinal segment within C4-C7, complete injury)
- Patients with spinal cord injury caused by penetrating trauma such as gunshot or stab wounds
- Patients with complete transection on the spinal cord
- Patients with spinal cord injury that require more than the mono-segment treatment
- Patients with other complications, including neurological defects related to peripheral nerve injury (neuromuscular injury or central spinal cord syndrome), or etiological causes of paraplegia or sensorimotor defects...
- Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination
- Patients administered with cells excluding blood transfusion before participating in the clinical study
- Patients with the following intercurrent diseases or conditions:
- Coagulopathy with INR\> 1.4 at the time of administration of the investigational product (Day 0)
- Active infection
- Active hypotension requiring vasoconstrictor treatment (less than 60 mmHg of diastolic blood pressure)
- Rupture of the skin on the area of surgery
- Medical history of malignant tumor
- Primary or secondary immunodeficiency
- Clinically significant abnormal values discovered as a result of laboratory tests
- Creatinine \> 1.5 mg/dL
- When the level found in the liver-function examination is more than twice the upper limit of the normal level
- Hematocrit/hemoglobin \<30%/10 g/dL
- Total WBC \< 1000/μL
- Uncontrolled hypertension (systole\> 180 mmHg or diastole\> 100 mmHg)
- Uncontrolled diabetes (HbA1c\> 8%)
- Evidence of GI bleeding on the stool guaiac test
- Positive on tuberculosis test (However, a chest X-ray may be performed if found positive on the TB test, and the patient may be enrolled upon no findings that suggest active tuberculosis on the chest X-ray.)
- Hepatitis B or C
- Human Immunodeficiency Virus (HIV)
- Substance abuse or alcoholism
- Unstable or untreated psychiatric disorder
- Patients with known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone, or prednisone
- Patients incapable of receiving physical therapy or combination therapy
- Patients incapable of going under general anesthesia due to other reasons
- Patients judged unsuitable for participation in this clinical study by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Suwon, Gyeonggido, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suwon, Gyeonggido, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.