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Phase 2 study of treatment for spinal cord injury(ASIA impairment scale A,B) with autologous mononuclear cells derived from bone marrow

Phase 2 study of treatment for spinal cord injury(ASIA impairment scale A,B) with autologous mononuclear cells derived from bone marrow - Phase 2 study of treatment for spinal cord injury with autologous mononuclear cells

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015741
Enrollment
20
Registered
2014-11-23
Start date
2014-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal cord injury

Interventions

Sponsors

Department of plastic surgery, Kitano hospital
Lead Sponsor
Shiga University of Medical Science
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with spinal cord injuries classified as A or B on the ASIA impairment scale 2.Patients within 3 weeks after injury 3.Patients with partial spinal cord injury demonstrated by diagnostic imaging 4.Patients aged between 20 and 60 years at the acquisition of informed consent 5.Patients who submitted written informed consent by themselves

Exclusion criteria

Exclusion criteria: 1.Patients with a completely transected spinal cord 2.Patient with spinal shock 3.Patients with central spinal cord injury 4.Patients with organ failure with a SOFA score of 3 points or higher 5.Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, adult T-cell leukemia, or parvovirus B19 infection could not be ruled out 6.Patients with malignant tumor or a history of malignant tumor within 5 years 7.Patients with one of the following diseases/disorders: ?Myeloproliferative disorder or myelodysplastic syndrome ?Autoimmune disease ?Spinal stenosis ?Limb paralysis due to central nervous system disorder not attributed to spinal cord injury ?Poorly controlled psychiatric disorder 8.Patients who were participating in other clinical trials or who completed participation within 6 months 9.Patients who were pregnant or possibly pregnant 10.Other patients who were judged to be ineligible by the investigators

Design outcomes

Primary

MeasureTime frame
To investigate the recovery of motor and sensory function after transplantaion of bone marrow-derived mononuclear cells into cerebrospinal fluid of patients with subacute spinal injury

Secondary

MeasureTime frame
Type and grade of adverse events Frequency of adverse events

Countries

Japan

Contacts

Public ContactYoshihisa Suzuki

The Tazuke Kofukai Medical Research Institute, Kitano Hospital Plastic surgery, 5 th laboratory

yo-suzuki@kitano-hp.or.jp06-6312-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026