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Adipose tissue-derived stem cell (ADSCs) transplantation study for lumbar spinal stenosis

An open-label study on the safety of adipose tissue-derived stem cell (ADSCs) transplantation for pain relief from lumbar spinal stenosis - OL-ADSC-TP-LSS

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb050220120
Enrollment
5
Registered
2022-11-21
Start date
2022-11-21
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

lumbar spinal stenosis

Interventions

A needle is used to transplant ADSCs near the degenerated or neuropathy site (intravertebral disc or epidural space). At that time, an echo guide, an X-ray fluoroscope, etc. are used together as neces

Sponsors

Sobajima Satoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients who have been diagnosed with lumbar spinal stenosis and whose affected area can be identified by clinical examinations. - Being 20 years old or older at the time of obtaining consent - No improvement in standard conservative therapy covered by insurance - Do not request surgical treatment at the time of obtaining consent - After receiving sufficient explanation about this research, consent should be obtained in writing from the person himself. - Being able to comply with the set schedule

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from this trial. - Patients who have difficulty in subcutaneous liposuction - Patients whose causative lesion is difficult to identify by preoperative examination - Patients with cancer - Patients using anticancer drugs, biopharmacy or immunosuppressants - Patients with active infection - Patients who have received this treatment within 1 month - Patients with serious complications (heart disease, lung disease, liver disease, kidney disease, bleeding tendency, uncontrolled diabetes and hypertension, etc.) that the attending physician or regenerative medicine provider deems inappropriate - Patients with a history of drug hypersensitivity to anesthetics, etc. - Other patients who the doctor in charge deems inappropriate

Design outcomes

Primary

MeasureTime frame
Adverse events

Secondary

MeasureTime frame
Visual analogue scale (VAS), Zurich Claudication Questionnaire (ZCQ), Numeric Rating Scale (NRS), and Roland-Morris Disability Questionnaire (RDQ), JOA score, Neurological examination, MRI and X-ray imaging (1 month, 3months, and 6 months after treatment)

Countries

Japan

Contacts

Public ContactYusuke Harada

Sobajima Clinic

harada@soba-cli.com+81-6-4309-1225

Outcome results

None listed

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