NCT04812431: SB-SCI-001

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)

Recruiting now Phase 1/Phase 2 Last updated 14 May 2025

What this trial tests

Phase 1/Phase 2 trial testing Neural precursor cells derived from human embryonic stem cell line in Spinal Cord Injury, Acute in 5 participants. Currently enrolling.

Timeline

23 September 2021

Primary endpoint
1 October 2028

1 September 2030

Quick facts

Lead sponsor	S.Biomedics Co., Ltd.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	23 September 2021
Primary completion	1 October 2028
Estimated completion	1 September 2030
Sites	2 locations across South Korea

Drugs / interventions tested

• Neural precursor cells derived from human embryonic stem cell line — full drug profile →

Conditions studied

• Spinal Cord Injury, Acute — all drugs for Spinal Cord Injury, Acute →
• Spinal Cord Injury at C4 Level With Complete Lesion — all drugs for Spinal Cord Injury at C4 Level With Complete Lesion →
• Spinal Cord Injury at C5-C7 Level With Complete Lesion — all drugs for Spinal Cord Injury at C5-C7 Level With Complete Lesion →

Sponsor

S.Biomedics Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injury, Acute or Spinal Cord Injury at C4 Level With Complete Lesion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advancements in Human Embryonic Stem Cell Research: Clinical Applications and Ethical Issues.
   Park SJ, Kim YY, Han JY, Kim SW, et al · · 2024 · cited 29× · PMID 38502279 · DOI 10.1007/s13770-024-00627-3
2. Clinical Trials Targeting Secondary Damage after Traumatic Spinal Cord Injury.
   Khaing ZZ, Chen JY, Safarians G, Ezubeik S, et al · · 2023 · cited 26× · PMID 36835233 · DOI 10.3390/ijms24043824
3. Human Neural Stem Cells for Cell-Based Medicinal Products.
   Fernandez-Muñoz B, Garcia-Delgado AB, Arribas-Arribas B, Sanchez-Pernaute R. · · 2021 · cited 24× · PMID 34572024 · DOI 10.3390/cells10092377
4. Molecular Mechanisms and Clinical Application of Multipotent Stem Cells for Spinal Cord Injury.
   Szymoniuk M, Litak J, Sakwa L, Dryla A, et al · · 2022 · cited 20× · PMID 36611914 · DOI 10.3390/cells12010120
5. Pluripotent Stem Cells for Spinal Cord Injury Repair.
   Martin-Lopez M, Fernandez-Muñoz B, Canovas S. · · 2021 · cited 19× · PMID 34943842 · DOI 10.3390/cells10123334
6. Cell transplantation to repair the injured spinal cord.
   Hall A, Fortino T, Spruance V, Niceforo A, et al · · 2022 · cited 10× · PMID 36424097 · DOI 10.1016/bs.irn.2022.09.008
7. Cell Transplantation for Repair of the Spinal Cord and Prospects for Generating Region-Specific Exogenic Neuronal Cells.
   Roman A, Huntemer-Silveira A, Waldron MA, Khalid Z, et al · · 2024 · cited 8× · PMID 38590295 · DOI 10.1177/09636897241241998
8. Bridging the gap: a translational perspective in spinal cord injury.
   Hassan OI, Takamiya S, Asgarihafshejani A, Fehlings MG. · · 2024 · cited 4× · PMID 39391076 · DOI 10.3389/ebm.2024.10266