About the clinical trial of autologous cultured chondrocyte transplantation conducted at our hospital

 

 

We are looking for patients who can cooperate in clinical trials of autologous cultured chondrocyte transplantation.

There are some criteria for participating in the clinical trial, so if you are interested, please contact the orthopedic department of our hospital.

 

■Outline of the clinical trial

This clinical trial is for patients who have partially lost (defective) cartilage in the knee joint due to trauma such as injury, or transection where the cartilage has come off due to load on the bone under the cartilage. For patients with gonadochondritis who meet certain criteria, autologous cultured chondrocyte transplantation or microscopic therapy, which is currently the standard treatment, is performed. You will receive one of the fracture treatments.

After that, we will examine the efficacy and safety by comparing the results of each treatment method.

 

■ Autologous cultured chondrocyte transplantation

From the patient's own knee, we collect normal cartilage that does not bear the weight of the femur and is not damaged. . These chondrocytes are transplanted into a place where cartilage has disappeared (called a cartilage defect site) together with fibrin glue, which works like glue in vivo. How to do it.

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The autologous cultured chondrocytes used in this clinical trial will be transplanted to humans for the first time, but animal experiments have confirmed that transplanting autologous cultured chondrocytes together with fibrin glue can repair cartilage defects.

 

What is microfracture treatment?

Microfracture therapy is now the standard treatment. This treatment method, called bone marrow stimulation therapy, is a treatment method in which a hole is made in the bone under the cartilage and the bone marrow cells present in the bone are introduced to promote cartilage regeneration.

 

■ Participation Criteria for Clinical Trials

[Target]

Patients diagnosed with traumatic cartilage deficiency or osteochondritis dissecans in only one knee and who have symptoms such as pain and tightness in the knee joint.

●Patients over 20 years old (male/female)

●Patients with a cartilage defect area of 2㎠ or more and 9㎠ or less (confirmed by a doctor during knee arthroscopy)

 

 

[Those who are not eligible] *If even one item is applicable, you cannot participate in the clinical trial.

●Patients with the following knee joint diseases

・Osteoarthritis of the knee

Inflammatory arthritis associated with autoimmune diseases such as rheumatoid arthritis

・Inflammatory arthritis such as gout

●Patients with cartilage defects in the knee joints of both legs or patients with multiple cartilage defects

Women who are pregnant or breastfeeding, and women and men who do not use contraception during the study period

●Patients who have received radiotherapy or anticancer drug treatment within the last 2 years

-Patients who have participated in other clinical trials within the last 6 months

●Patients who are judged ineligible to participate in the clinical trial by the attending physician

 

In addition to the above, there are some criteria for [eligible] and [non-eligible].

Please understand that you may not be able to participate depending on the patient's condition.

 

■ Period of participation in the clinical trial

・The period of participation in the clinical trial is approximately 1 year and 3 months.

(Participation period may vary depending on inspection schedule, etc.)

In addition, we will ask you to visit us to check the condition of your knee joint 1 year and 2 years after the end of the clinical trial.

・A knee arthroscopy will be performed at the start and end of the clinical trial, so there may be times when you need to be hospitalized.

・The interval between outpatient visits during the clinical trial period will be every 13 weeks (approximately once every 3 months), with some exceptions.

 

 

For more information, feel free to contact us below.

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Clinical trial clinical department: Orthopedics

Contact: Muneshi Uchida (Investigator)

Phone number (093) 761-0090

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