臨床研究等提出・公開システム

An open-label study on the safety of knee osteoarthritis treatment with adipose tissue-derived stem cells produced using a three-dimensional culture substrate (S-KOA-ADSC-3d-CS)

Knee osteoarthritis treatment using three-dimensionally manufactured adipose tissue-derived stem cells (KOA-3d-ADSC)

Sobajima Satoshi

Sobajima Satoshi

Sobajima Clinic

Clinic Court Higashino , Aramto Kita, Higash i Osaka city, Osaka

orthohealing@soba-cli.com

Harada Yusuke

Sobajima Clinic

Clinic Court Higashino , Aramto Kita, Higash i Osaka 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 with functional impairment associated with knee osteoarthritis
-Must be 20 years of age or older at the time of obtaining consent
-Diagnosed with osteoarthritis of the knee at our hospital, and there is no improvement even after implementing standard conservative therapy (hyaluronic acid injection and physical therapy) that is fully covered by insurance for more than 3 months
-After performing standard conservative therapy for 3 months or more, the value of pain evaluation by visual analogue scale must be 40 or more.
- Do not wish to undergo artificial joint replacement surgery or osteotomy
-Written consent must be obtained from the individual after receiving a sufficient explanation about this research.
-Ability to adhere to a set schedule

Patients with any of the following are excluded.
-Patients for whom subcutaneous liposuction is difficult
-Patients with cancer
-Patients using anticancer drugs, biologics, or immunosuppressants
-Patients who are pregnant, breastfeeding, or may become pregnant
-Patients with active infection
-Patients who have received Ch-ADSCs transplantation into the knee joint cavity in the past
-Patients who have serious complications (cardiac disease, lung disease, liver disease, renal disease, bleeding tendency, uncontrolled diabetes, hypertension, etc.) and are judged unsuitable by a doctor
-Patients with a history of drug hypersensitivity to anesthetics, etc.
-Other patients who are deemed inappropriate by the attending physician

Both

Knee osteoarthiritis

Under echo guidance, administer Ch-ADSCs intra-articularly using a 21G injection needle. Approximately 20 million cells should be injected per time.

[Occurrence rate of adverse events 26 weeks after Ch-ADSCs transplantation]
Regarding adverse events, we will calculate the frequency of the worst grade from fat collection by CTCAE v5.0-JCOG to 26 weeks later.

[Efficacy 26 weeks after Ch-ADSCs transplantation]
To evaluate the efficacy of Ch-ADSCs transplantation, pain evaluation by VAS listening, KOOS evaluation, and MRI image evaluation will be performed. VAS and KOOS evaluations are performed at enrollment and 4, 12, and 26 weeks after Ch-ADSCs transplantation. MRI examinations are performed at enrollment and 26 weeks. There are two types of MRI imaging conditions: normal imaging such as PD and T2 star MERGE, and T2 mapping. For evaluation, MRI osteoarthritis knee score (MOAKS) is used to evaluate bone marrow lesions, cartilage defects, osteophytes, synovitis, and joint edema, and cartilage is evaluated by T2 mapping.

Not Recruiting

+81-3-3265-4804

April. 04, 2023