Transplantation therapy using neural precursor cells for spinal cord injury
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 is testing if using special cells from human embryos can help people with recent spinal cord injuries feel better and recover some function.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | S.Biomedics Co., Ltd. Industry-sponsored |
| Drugs / interventions | basiliximab, prednisone |
| Locations | 2 sites (Suwon, Gyeonggido and 1 other locations) |
| Trial ID | NCT04812431 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and exploratory efficacy of transplantation therapy using PSA-NCAM(+) neural precursor cells derived from human embryonic stem cells in patients with sub-acute spinal cord injuries classified as AIS-A. The study involves administering these cells to subjects with complete lesions at the C4 to C7 levels and monitoring for dose-limiting toxicities. Depending on the occurrence of these toxicities, the number of enrolled subjects may vary, and a series of follow-up visits will be conducted over a period of at least 68 weeks to assess outcomes. The trial aims to provide insights into the potential therapeutic effects of this innovative cell therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female patients aged 18 to 65 who have sustained a spinal cord injury classified as AIS-A within 7 to 60 days prior to treatment.
Not a fit: Patients with spinal cord injuries classified as AIS-B or higher, or those outside the specified age range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could lead to improved recovery and reduced paralysis in patients with spinal cord injuries.
How similar studies have performed: While the use of neural precursor cells in spinal cord injury treatment is a novel approach, similar studies have shown promise in regenerative medicine, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Upon written consent of the patient or the legally acceptable representative of the patient
2. Male and female patients 18 to 65 years of age
3. 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
4. Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury
5. 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
6. Patients whose ASIA Impairment Scale (AIS) satisfies AIS-A criteria (spinal segment within C4-C7, complete injury)
Exclusion Criteria:
1. Patients with spinal cord injury caused by penetrating trauma such as gunshot or stab wounds
2. Patients with complete transection on the spinal cord
3. Patients with spinal cord injury that require more than the mono-segment treatment
4. 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
5. Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination
6. Patients administered with cells excluding blood transfusion before participating in the clinical study
7. Patients with the following intercurrent diseases or conditions:
1. Coagulopathy with INR\> 1.4 at the time of administration of the investigational product (Day 0)
2. Active infection
3. Active hypotension requiring vasoconstrictor treatment (less than 60 mmHg of diastolic blood pressure)
4. Rupture of the skin on the area of surgery
5. Medical history of malignant tumor
6. Primary or secondary immunodeficiency
7. 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)
8. Substance abuse or alcoholism
9. Unstable or untreated psychiatric disorder
8. Patients with known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone, or prednisone
9. Patients incapable of receiving physical therapy or combination therapy
10. Patients incapable of going under general anesthesia due to other reasons
11. Patients judged unsuitable for participation in this clinical study by the investigator
Where this trial is running
Suwon, Gyeonggido and 1 other locations
- Ajou University Hospital — Suwon, Gyeonggido, South Korea (Recruiting)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Dong Ah Shin, MD — Yonsei University Health System, Severance Hospital
- Study coordinator: Sarang Kim
- Email: info@sbiomedics.com
- Phone: +82 70-2205-0023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.