RecruitingPhase 1/2

Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI

South Korea5 participantsStarted 2021-09-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion 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, 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\*
✓. 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)

Exclusion criteria

✕. 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

What they're measuring

Changes of occurred adverse events during the clinical study

Timeframe: 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

Timeframe: Visit 1(Screening), Visit 11(72 weeks)

Measured changes of Systolic blood pressure (mm Hg)

Timeframe: 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)

Measured changes of Heart rate (beats per minute)

Measured changes of Respiratory rate (breaths per minute)

Trial details

NCT IDNCT04812431

SponsorS.Biomedics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Sarang Kim

+82 70-2205-0023 info@sbiomedics.com

View on ClinicalTrials.gov More Spinal Cord Injury, Acute trials