WJ-MSC for Chronic Complete Spinal Cord Injury, Phase I — Kaplan et al.
Safety and motor function assessment of intrathecal WJ-MSC administration in patients with chronic complete spinal cord injury.
| Trial ID | NCT05152290 ↗ |
|---|---|
| Sponsor | Stem Cell of America · USA |
| Cell Source | 와튼젤리 중간엽줄기세포 (WJ-MSC) · allogeneic |
| Indication | 척수손상 · Spinal Cord Injury |
| Phase | PHASE 1 |
| Status | ACTIVE |
| Delivery Route | intrathecal |
| Enrollment | 10 |
| Publication | — |
Trial Design
A Phase I clinical trial of intrathecal administration of Wharton’s jelly-derived MSCs in patients with chronic complete spinal cord injury. The primary endpoint is safety; secondary endpoints include changes on the ASIA Impairment Scale, motor and sensory function, autonomic function, and pain and spasticity scores.
Clinical Significance
Chronic spinal cord injury is one of the most challenging indications in the field of stem cell therapy. In the acute phase following injury, there is reasonable expectation of benefit from anti-inflammatory and neuroprotective effects; however, as injury progresses into the chronic phase, neuronal death becomes complete and glial scar tissue forms, rendering regeneration exceedingly difficult.
The decision to enrol chronic patients is therefore significant. Should safety and even modest functional recovery signals be confirmed, a large and underserved patient population — those for whom time has already elapsed since the initial injury — may gain access to a new therapeutic option.
The rationale for applying WJ-MSCs to spinal cord injury rests on the following mechanisms:
- Anti-inflammatory and immunomodulatory effects — suppression of neuroinflammation that persists even in the chronic phase
- Neurotrophic factor supply via the secretome — including BDNF, NT-3, and GDNF
- Promotion of angiogenesis — improved blood flow to the injury site
- Modulation of scar formation — preclinical evidence of glial scar reduction reported in some models
Limitations
- Clinically meaningful recovery of motor function in chronic-phase patients remains limited even in preclinical models.
- Intrathecal delivery is invasive and carries an inherent risk of procedural complications.
- The absence of a placebo control requires cautious interpretation of any efficacy signal.
Related Trials
More than 50 stem cell trials targeting spinal cord injury are ongoing worldwide, employing a range of cell sources including bone marrow MSCs, neural stem cells (NSCs), and olfactory ensheathing cells (OECs). WJ-MSCs represent a relatively recent entrant into this therapeutic area.