February 28, 2024
Japan Tissue Engineering Co., Ltd.

Autologous Cultured Cartilage JACC:
Progress in Clinical Trial aimed at Expanding Indication for Knee Osteoarthritis
Japan Tissue Engineering Co., Ltd. (Headquarters: Gamagori, Aichi Prefecture; President andCEO: Ken-ichiro Hata) is seeking an expansion of indication*1 for the regenerative medical product"Autologous Cultured Cartilage JACC®" (hereinafter JACC), which is used to treat traumatic
cartilage defects or osteochondritis dissecans of the knee.
We have recently notified the Pharmaceuticals and Medical Devices Agency (PMDA) of thecompletion of our clinical trial for expanding indications (hereinafter referred to as “the Trial"). The
progress of the Trial is as follows.
1. Overview of the Trial
The purpose of the Trial is to verify the efficacy and safety of JACC by multicenter, parallelgroup clinical trial compared with intra-articular injection of sodium hyaluronate (HA) in patientswith knee osteoarthritis*2. The target number of patients in the Trial was set at 58, and patientswere randomly assigned to receive either transplantation of JACC or intra-articular injection ofHA. Treatment for the final case as well as follow-up observation for all cases have beencompleted. We have fixed the data obtained through the Trial concerning the cases andconducted a data analysis with regard to efficacy and safety. The results are outlined below.
2. Key analysis resultsl Primary outcomes
It was statistically shown that, in terms of change in WOMAC score between pre andpost treatment, JACC group improved significantly compared to HA group. (P<0.0001
Student's t-test)
WOMAC（Western Ontario and McMaster Universities Osteoarthritis Index）score: Evaluation score based on patient’sclinical symptoms.

l

Key secondary outcomes
The presence or absence of repair with hyaline cartilage-like tissue (HCT) , which is oneof the key secondary evaluation items, was determined comprehensively by theindependent data monitoring committee (IDMC), based on the results of MRIexaminations, arthroscopic examinations, and histological evaluations. As a result,
97.4% of the cartilage defect sites evaluated in JACC group showed repair with HCT at
52 weeks post treatment.

lRegarding safety, no adverse events of concern were observed.

In addition to showing a statistically significant improvement in clinical symptoms compared to
the HA group, it is of a great significance that the transplantation of JACC repairs cartilage defects
caused by knee osteoarthritis with HCT.

Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022 Japan. https://www.jpte.co.jp/en

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[Comment from President Ken-ichiro Hata]
With the vision of “Creating a Future for Regenerative Medicine,” we have been striving toprovide more patients with regenerative medical products using patients' own cells. We believe
the results of the Trial are extremely important as they suggest the regeneration of damaged knee
joints with hyaline cartilage. We would like to express our deepest gratitude to the doctors at themedical institutions who conducted the Trial, as well as the patients who participated. We willswiftly compile data and prepare for manufacturing and sales applications, and continuously work
towards the development of regenerative medicine in Japan.
*1 Expansion of indication: To expand the scope of application of a drug for which marketing approval has already beenobtained (add diseases treatable with the drug)*2 Knee osteoarthritis: A disease that causes pain as the cartilage gradually wears away and deforms. In some cases,
the cause is not clear while, in other cases, it is possible to identify the cause such as sports- or accident-related
trauma. Aging and obesity lead to symptom progression. Currently, knee osteoarthritis is treated symptomatically byadministering analgesics with anti-inflammatory properties to alleviate pain and other clinical symptoms, whileretarding symptom progression is difficult. The methods to treat severe symptoms are limited to a few options such as
high tibial osteotomy in which the angle of the knee is adjusted by cutting the tibia and artificial joint replacement.

About autologous cultured cartilage
Autologous cultured cartilage (brand name: “JACC”), based on technology developed by Professor
Mitsuo Ochi (currently President of Hiroshima University) during his research at Shimane Medical
University, is Japan’s first regenerative medical product in the field of orthopedics.
“JACC” is made by harvesting the patient’s own cartilage tissue and mixing it with gel-form
atelocollagen to mold it into a three-dimensional form that is then transplanted at the site of cartilage
defects in the patient’s knee. “JACC” was approved in July 2012, and it has been covered by publichealth insurance programs since April 2013 in Japan.
In 2019, aiming to further reduce the invasiveness in regards to the patient’s body in treatment withJACC, we introduced the method of using an artificial collagen membrane instead of the periosteum
harvested from the patient’s tibia for transplantation. This reduced the physical burden on patients,
as well as simplifying the transplanting procedure for doctors.
Transplantation of autologous cultured cartilage (knee-joint)[Contact information for inquiries about this announcement]
Japan Tissue Engineering Co., Ltd.
E-mail. jtec-info@jpte.co.jp
Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022 Japan. https://www.jpte.co.jp/en2/2