Spinal Cord Injury, AcutePhase 1/2SB-SCI-001NCT04812431
Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
A Phase 1/2 study testing Neural precursor cells derived from human embryonic stem cell line in people with Spinal Cord Injury, Acute and Spinal Cord Injury at C4 Level With Complete Lesion, run by S.Biomedics Co., Ltd. at 2 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Acute, Spinal Cord Injury at C4 Level With Complete Lesion, Spinal Cord Injury at C5-C7 Level With Complete Lesion
- What is being tested?
- Neural precursor cells derived from human embryonic stem cell line
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Sep 2021to Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, ovariectomy, or sterilization operation), or male patients who have received vasectomy or are willing to use contraceptives for up to 90 days after administration of the investigational product using a dual contraceptive method*
- Dual contraceptive method: Method of using multiple contraceptives, such as using a cervical cap or contraceptive diaphragm in addition to a condom for males
- 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)
Who cannot join
- 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 related to an additional underlying condition
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Dong Ah Shin, MD, +82 2-2228-2150, CISTERN@yuhs.ac
- Recruiting
Ajou University Hospital
Suwon, Gyeonggido, 16499
Nam Gyu Yu, MD, nkyou@ajou.ac.kr
About this study
Official title: A Single Center, Open Label, Single Group, Phase 1/2a Clinical Study to Evaluate the Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC Derived From hESC Line in AIS-A Level of Sub-acute SCI(From 7 to 60 Days)
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.
Read the detailed description
Subjects with damage to C4-C7 cords diagnosed as AIS-A are administered with PSA-NCAM(+) NPC.
For evaluation of safety and exploratory efficacy, 2 to 6 subjects will be enrolled depending on the presentation of dose-limiting toxicity.
When the Dose Limiting Toxicity (DLT) is not presented in the first three subjects administered with PSA-NCAM(+) NPC, two additional patients are added to the clinical study. When the DLT is presented in two or more of the first three patients, the clinical study is discontinued; when the DLT is presented in one of the three patients, three additional new patients are added. In case of presentation of the DLT in at least one of the three additional patients, the study is discontinued; the clinical study is continued only when the DLT is not presented in all three patients.
Screening visit (Visit 1), surgery and recovery visit (Visit 2 to Visit 6), follow-up visit (Visit 7 to Visit 8 + phone screening I, II, III), additional visit (Visit 9 to Visit 10), and close-out visit (Visit 11) are conducted. A clinical study period of at least 68 weeks is secured after Visit 6 (at least 5 visits and 3 phone screenings).
All subjects are to be conducted of follow-up study of a period of 1 year and 5 months at Weeks 1, 2, 4, 8, 12, 24, 48, and 72 after surgery.
- Conditions
- Spinal Cord Injury, Acute, Spinal Cord Injury at C4 Level With Complete Lesion, Spinal Cord Injury at C5-C7 Level With Complete Lesion
- Being tested
- Neural precursor cells derived from human embryonic stem cell line
- Keywords
- Spinal cord injury, AIS-A
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural precursor cells derived from human embryonic stem cell lineBiological
When the Dose Limiting Toxicity (DLT) is not presented in the first three subjects administered with PSA-NCAM(+) NPC, two additional patients are added to the clinical study.
| Study group | Role | What they receive |
|---|---|---|
| PSA-NCAM(+) NPC | Experimental | Cells are administered through intrathecal injection. Injection is administered to a total of five areas. Receives: Biological: Neural precursor cells derived from human embryonic stem cell line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of occurred adverse events during the clinical study
Assessment of the presentation rate of adverse events occurred from IP administration until the end of the clinical study (Visit 11).
Measured: Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks), Telephone visit 1(13 weeks), Telephone visit 2(14 weeks), Telephone visit 3(16 weeks)
Rate of abnormal signs as assessed through physical examination
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as assessed through physical examination (appearance, skin, head/neck, chest/lung, heart, abdomen, genitourinary system, extremities, musculoskeletal system, nervous system, and lymph nodes).
Measured: Visit 1(Screening), Visit 11(72 weeks)
Measured changes of Systolic blood pressure (mm Hg)
Comparative assessment of measured value using systolic blood pressure (mm Hg) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Measured changes of Body temperature (degrees Celsius)
Comparative assessment of measured value using body temperature (degrees Celsius) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Measured changes of Heart rate (beats per minute)
Comparative assessment of measured value using heart rate (beats per minute) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Measured changes of Respiratory rate (breaths per minute)
Comparative assessment of measured value using respiratory rate (breaths per minute) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Rate of abnormal hematology values
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using hematology values(WBC, WBC differential, RBC, Hemoglobin, Hematocrit, and Platelet).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Rate of abnormal chemistry values
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using chemistry values(Sodium, Potassium, Calcium, Chloride, Inorganic Phosphate, SGOT(AST), SGPT(ALT), Alkaline Phosphatase, GGT, Creatinine, BUN, Total Bilirubin, Total Protein, Albumin, and Glucose).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Rate of abnormal urinalysis values
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using urinalysis values(Protein, Glucose, Ketones, and Occult Blood).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Measured changes of diastolic blood pressure (mm Hg)
Comparative assessment of measured value using diastolic blood pressure (mm Hg) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Secondary outcomes (8)
Assessment of Graft survival at the transplant site as observed in MRI examination
Number of participants with measured value(spinal cord changes, spinal cord atrophy far from the lesion, edema, cystic degeneration, spinal sinus, and diameter change) using MRI examination.
Measured: Visit 1(Screening), Visit 11(72 weeks)
Number of participants with Transplant rejection against transplanted cells
Comparative Assessment of PSA-NCAM(+) NPC-specific antibody that may result in transplant rejection in the HLA antigen/antibody reaction test.
Measured: Visit 1(Screening), Visit 6(4 weeks)
Changes in the ASIA Damage Scale
Number of participants with changes in ISNCSCI ASIA at Week 12 (Visit 8) and Week 72 (Visit 11) of administration compared to the baseline (Visit 1).
Measured: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
International standards for neurological classification of spinal cord injury (ISNCSCI) motor index score
Number of participants with motor level recovered* at Week 4 (Visit 6), Week 12 (Visit 8), Week 24 (Visit 9), Week 48 (Visit 10), and Week 72 (Visit 11) of drug administration compared to the baseline (Visit 1).
- Recovery: Subjects with recovery of at least 2 stages in the upper limb motor score
Measured: Visit 1(Screening), Visit 6(4 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Measured changes of International standards for neurological classification of spinal cord injury (ISNCSCI) sensory index score
Rate of changes in the total ISNCSCI ASIA sensory index score at Week 12 (Visit 8) and Week 72 (Visit 11) of administration compared to the baseline (Visit 1).
Measured: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Pain assessment
Rate of measured changes in the pain scores at Week 12 (Visit 8) and Week 72 (Visit 11) compared to the baseline (Visit 1).
Measured: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Spinal Cord Independence Measure (SCIM) score
Rate of change in the SCIM score at Week 12 (Visit 8) and Week 72 (Visit 11) compared to the baseline (Visit 1).
Measured: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Measured changes of International standards for neurological classification of spinal cord injury (ISNCSCI) motor index score
Rate of changes in the total ISNCSCI ASIA motor score at Week 12 (Visit 8) and Week 72 (Visit 11) of administration compared to the baseline (Visit 1).
Measured: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start23 Sep 2021
- Primary completionOct 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects with damage to C4-C7 cords diagnosed as AIS-A are administered with PSA-NCAM(+) NPC.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.Biomedics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Linical Co., Ltd., Yonsei University
- Responsible party
- Sponsor
- Investigators
- Dong Ah Shin, MD, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812431
- Sponsor's protocol ID
- HI20C0168000020
- Acronym
- SB-SCI-001
- Status last verified
- May 2025
- First submitted
- 24 Feb 2021
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Single Group, Phase 1/2a Clinical Study to Evaluate the Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC Derived From hESC Line in AIS-A Level of Sub-acute SCI(From 7 to 60 Days)
- ClinicalTrials.gov ID
- NCT04812431
- Acronym / sponsor ID
- SB-SCI-001 / HI20C0168000020
- Conditions
- Spinal Cord Injury, Acute, Spinal Cord Injury at C4 Level With Complete Lesion, Spinal Cord Injury at C5-C7 Level With Complete Lesion
- Keywords
- Spinal cord injury, AIS-A
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- S.Biomedics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Linical Co., Ltd., Yonsei University
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects with damage to C4-C7 cords diagnosed as AIS-A are administered with PSA-NCAM(+) NPC.
For evaluation of safety and exploratory efficacy, 2 to 6 subjects will be enrolled depending on the presentation of dose-limiting toxicity.
When the Dose Limiting Toxicity (DLT) is not presented in the first three subjects administered with PSA-NCAM(+) NPC, two additional patients are added to the clinical study. When the DLT is presented in two or more of the first three patients, the clinical study is discontinued; when the DLT is presented in one of the three patients, three additional new patients are added. In case of presentation of the DLT in at least one of the three additional patients, the study is discontinued; the clinical study is continued only when the DLT is not presented in all three patients.
Screening visit (Visit 1), surgery and recovery visit (Visit 2 to Visit 6), follow-up visit (Visit 7 to Visit 8 + phone screening I, II, III), additional visit (Visit 9 to Visit 10), and close-out visit (Visit 11) are conducted. A clinical study period of at least 68 weeks is secured after Visit 6 (at least 5 visits and 3 phone screenings).
All subjects are to be conducted of follow-up study of a period of 1 year and 5 months at Weeks 1, 2, 4, 8, 12, 24, 48, and 72 after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects with damage to C4-C7 cords diagnosed as AIS-A are administered with PSA-NCAM(+) NPC.
| Arm | Type | Receives |
|---|---|---|
| PSA-NCAM(+) NPC | Experimental | Biological: Neural precursor cells derived from human embryonic stem cell lineCells are administered through intrathecal injection. Injection is administered to a total of five areas. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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, ovariectomy, or sterilization operation), or male patients who have received vasectomy or are willing to use contraceptives for up to 90 days after administration of the investigational product using a dual contraceptive method*
- Dual contraceptive method: Method of using multiple contraceptives, such as using a cervical cap or contraceptive diaphragm in addition to a condom for males
- Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury
Key exclusion criteria (30 listed)
- 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 related to an additional underlying condition
- Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural precursor cells derived from human embryonic stem cell lineWhen the Dose Limiting Toxicity (DLT) is not presented in the first three subjects administered with PSA-NCAM(+) NPC, two additional patients are added to the clinical study. | Biological | PSA-NCAM(+) NPC |
Primary outcome
Changes of occurred adverse events during the clinical study
Time frame: Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks), Telephone visit 1(13 weeks), Telephone visit 2(14 weeks), Telephone visit 3(16 weeks)
Assessment of the presentation rate of adverse events occurred from IP administration until the end of the clinical study (Visit 11).
Rate of abnormal signs as assessed through physical examination
Time frame: Visit 1(Screening), Visit 11(72 weeks)
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as assessed through physical examination (appearance, skin, head/neck, chest/lung, heart, abdomen, genitourinary system, extremities, musculoskeletal system, nervous system, and lymph nodes).
Measured changes of Systolic blood pressure (mm Hg)
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using systolic blood pressure (mm Hg) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured changes of Body temperature (degrees Celsius)
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using body temperature (degrees Celsius) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured changes of Heart rate (beats per minute)
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using heart rate (beats per minute) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured changes of Respiratory rate (breaths per minute)
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using respiratory rate (breaths per minute) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Rate of abnormal hematology values
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using hematology values(WBC, WBC differential, RBC, Hemoglobin, Hematocrit, and Platelet).
Rate of abnormal chemistry values
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using chemistry values(Sodium, Potassium, Calcium, Chloride, Inorganic Phosphate, SGOT(AST), SGPT(ALT), Alkaline Phosphatase, GGT, Creatinine, BUN, Total Bilirubin, Total Protein, Albumin, and Glucose).
Rate of abnormal urinalysis values
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using urinalysis values(Protein, Glucose, Ketones, and Occult Blood).
Measured changes of diastolic blood pressure (mm Hg)
Time frame: Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using diastolic blood pressure (mm Hg) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
8 secondary outcomes
Assessment of Graft survival at the transplant site as observed in MRI examination
Time frame: Visit 1(Screening), Visit 11(72 weeks)
Number of participants with Transplant rejection against transplanted cells
Time frame: Visit 1(Screening), Visit 6(4 weeks)
Changes in the ASIA Damage Scale
Time frame: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
International standards for neurological classification of spinal cord injury (ISNCSCI) motor index score
Time frame: Visit 1(Screening), Visit 6(4 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Measured changes of International standards for neurological classification of spinal cord injury (ISNCSCI) sensory index score
Time frame: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Pain assessment
Time frame: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Spinal Cord Independence Measure (SCIM) score
Time frame: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Measured changes of International standards for neurological classification of spinal cord injury (ISNCSCI) motor index score
Time frame: Visit 1(Screening), Visit 8(12 weeks), Visit 11(72 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong Ah Shin, MD principal investigator
Yonsei University Health System, Severance Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neural precursor cells derived from human embryonic stem cell line in people with Spinal Cord Injury, Acute and Spinal Cord Injury at C4 Level With Complete Lesion, run by S.Biomedics Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarang Kim (+82 70-2205-0023, info@sbiomedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of occurred adverse events during the clinical study (time frame: Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks), Telephone visit 1(13 weeks), Telephone visit 2(14 weeks), Telephone visit 3(16 weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.