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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorS.Biomedics Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Neural precursor cells derived from human embryonic stem cell line

Treatment groups

5 Participants
are divided into 1 treatment group

Sponsors and collaborators

S.Biomedics Co., Ltd.

Lead sponsor

Linical Co., Ltd.

Collaborator

Yonsei University

Collaborator