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Open-label trial on the safety of Adipose tissue-derived stem cell spheroid (S-ADSCs) transplantation using an adhesive culture vessel for knee osteoarthritis (Olt-S-ADSCKOA)

Clinical trial of adipose tissue-derived stem cell spheroids transplantation for knee osteoarthritis (S-ADSCKOA)

Sobajima Satoshi

Dec. 22, 2021

5

The median age was 65.6 years (48-76 years), 2 males and 3 females. Median weight was 59.2 kg and median BMI was 22.2. None had underlying medical conditions.

Five patients are scheduled to be enrolled and 24-week follow-up after cell transplantation, while 5 patients have completed enrollment, cell transplantation, and 24-week follow-up at the time of writing this report. Also, no one dropped out during the follow-up period.

In the liposuction performed in this study, no occurrence of adverse events including hematoma around the liposuction site was observed. In the S-ADSCs transplantation performed in this study, no adverse events such as swelling and pain around the joint were observed after cell transplantation. No serious or non-serious adverse events were observed at the 24-week follow-up after cell transplantation.

Primary endpoint: Safety 24 weeks after S-ADSCs transplantation No infections, local lesions, masses, etc. were observed during the entire period of the 5 subjects who participated in this study. In the liposuction performed in this study, no occurrence of adverse events including hematoma around the liposuction site was observed. In the S-ADSCs transplantation performed in this study, no adverse events such as swelling and pain around the joint were observed after cell transplantation. No serious or non-serious adverse events were observed at the 24-week follow-up after cell transplantation. In the confirmation of the general condition, no abnormal findings were observed throughout the period. Secondary endpoint: efficacy 24 weeks after S-ADSCs transplantation 1. MRI image evaluation Image evaluation of knee joints by MRI was performed before cell transplantation and 24 weeks after transplantation for 5 subjects who participated in this study. As a result, in all cases, no change in MRI images due to cell transplantation was observed compared to before surgery. 2. WOMAC, JKOM, KOOS For WOMAC, JKOM, and KOOS, when the total scores at the time of preoperative evaluation were compared at each stage of 4 weeks, 12 weeks, and 24 weeks after cell transplantation, significant improvement or a tendency toward improvement was observed at 12 weeks after transplantation, and 24 weeks after transplantation. Significant improvement was noted at week.

It was suggested that S-ADSCs transplantation for knee osteoarthritis in 5 patients has a certain level of safety. This study was conducted in a small number of cases, and more cases are needed to determine its efficacy. It was suggested.

Dec. 27, 2022

No

https://jrct.mhlw.go.jp/latest-detail/jRCTb050200097

Sobajima Satoshi

Sobajima Clinic

Clinic Court Higashino, Aramto Kita, Higashi Osaka city, Osaka

orthohealing@soba-cli.com

Fujii Misako

Sobajima Clinic

Clinic Court Higashino, Aramoto Kita 2-2-6, Higashi Osaka city, Osaka

+81-6-4309-1225

fujii@soba-cli.com

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Patients with dysfunction associated with osteoarthritis
-Over 20 years old when obtaining consent
-No improvement in standard conservative therapy for insurance indication
-Don't wish to perform artificial joint replacement or osteotomy
-Obtain written consent sufficient explanation about this study
-Able to comply with a fixed schedule

-Patients who have difficulty with subcutaneous liposuction
-Patients with cancer
-Patients who are using anti-cancer drugs, biologics or immunosuppressants
-Patients with active infection
-Patients who have recieved this treatment within a month
-Patients with serious complicaitons such as heart disease, liver diseaes, lung disease, kidny disease, bleeding tendency, uncontroled diabetes, hypertension, etc.
-Patients with a history of drug sensitivity to anesthetics
-Other patients judged inappropriate by doctors

Both

Knee osteoarthritis

Intraarticular administration of S-ADSCs using a 21G needle with echo guide. Dosing a full of one container in one injection. The cell suspension contains about 42,000 S-ADSCs.

Presence or absence of adverse event

Clinical score evaluation such as WOMAC, JKOM, KOOS (4 weeks, 12 weeks, and 24 weeks after treatment)
MRI image evaluation (24 weeks after treatment)

Complete

+81-52-745-6881

June. 10, 2020