臨床研究等提出・公開システム

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)

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

Satoshi Sobajima

Sobajima Satoshi

Sobajima Clinic

1F,2F,3F, Clinic Court Higashino, 2-2-6 Ara motokita, Higashiosaka City, Osaka

orthohealing@soba-cli.com

Harada Yusuke

Sobajima Clinic

1F,2F,3F, Clinic Court Higashino, 2-2-6 Ara motokita, Higashiosaka City, Osaka

+81-6-4309-1225

harada@soba-cli.com

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

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

Both

lumbar spinal stenosis

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 necessary. Administer intra-articularly. Dosing at least 20 million cells in one ingection.

Adverse events

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)

Recruiting

+81-52-745-6881

July. 26, 2022

No

none