A single-center, double-blind, placebo-controlled, randomized, parallel-group study to evaluate the efficacy and safety of Intraarticular injections of autologous synovial stem cells for knee osteoarthritis (Investigator initiated clinical trial)

JRCT ID: jRCT2033230017

Registered date:10/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Osteoarthritis of the knee
• Date of first enrollment: 04/04/2023
• Target sample size: 14
• Study type: Interventional

Intervention(s)

Intra-articular injection of the investigational product in patients with painful osteoarthritis of the knee joint who have had a continuous decrease in the thickness of the medial femoral cartilage of the knee joint for 30 weeks after consent is obtained.
For the autologous synovial stem cell group, a single dose of the investigational product (cell suspension containing stem cells) produced from the subject's synovial membrane is administered into the knee joint cavity.
For the placebo group, a solution adjusted from serum collected from the subject is administered into the knee joint cavity.
After 30 weeks of observation following administration, the blind is broken and subjects assigned to the placebo group are administered the investigational product manufactured from the subject's synovial membrane to those who wish to receive it.

Outcome(s)

• Primary Outcome: The amount of change will be compared between the autologous synovial stem cell group and the placebo group using the thickness of the posterior medial part of the femoral cartilage obtained by 3D image analysis of MRIs taken 1 week before and 30 weeks after protocol treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Select subjects who satisfy all of the following items.
1) Patients whose age is 20 years or older at the time of obtaining informed consent before clinical trial.
2) Patients whose written informed consent has been obtained.
3) Patients with Kellgren-Lawrence classification grade 2 or 3 osteoarthritis of knee on X-ray examination.
4) Patients with mean cartilage thickness at the posterior medial femoral condyle is 0.6 mm or more as calculated by MRI scan 30 weeks prior to administration of clinical trial.
5) Patients with clinical symptoms of pain in the knee.
6) Patients in whom hyaluronic acid injections for the treatment of osteoarthritis of the knee within 10 years prior to trial registration.
7) Patients in whom exercise therapy for at least 3 months for osteoarthritis of the knee.

Exclude criteria

Exclude any of the following.
[Before obtaining informed consent]
1) Patients with a history of surgery or arthroscopic examination in the affected knee.
2) Patients with a history of administration of PRP or cell injections in the affected knee.
3) Patients whose clinical symptoms including pain have been sufficiently improved by conservative treatments including rehabilitations in the last 3 months.
4) Patients who require meniscus suture or resection due to a catching sensation in the knee (symptoms of not smooth flexion and extension of the knee joint).
5) Patients who require meniscus suture or resection due to knee instability (Symptoms of lack of stability in the knee during daily life and exercise).
6) Patients with a history of obvious knee trauma, knee ligament injuries.
7) Patients for whom MRI is not indicated because of claustrophobia and so on.
8) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months.
9) Patients with active infection(including those who tested positive for infectious diseases).
10) Patients diagnosed or suspected as malignant tumor in these 5 years.
11) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B).
12) Patients sensitive to animal (bovine) origin materials.
13) Patients with poor controlled diabetes.
14) Patients with an implantable cardiac device (pacemaker, defibrillator).
15) Patients with categorized as non-bedridden(rank A)and bedridden (rank B and C).
16) Patients with difficulties in self-determination because of dementia and so on.
17) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study.
18) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product.
19) Patients for whom doctors decide as not appropriate to participate in the clinical study.
[At the time of the examination 15 weeks prior to the start of protocol treatment]
20) Patients whose reduction of cartilage thickness of the posterior medial femur of less than 0.05mm from 30 weeks to 15 weeks prior to the start of protocol treatment by MRI scan after consent obtained.
[At the start of protocol treatment]
21) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product.

Related Information

• Primary Sponsor: Sekiya Ichiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development