Unique ID issued by UMIN | UMIN000034801 |
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Receipt number | R000039592 |
Scientific Title | Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis |
Date of disclosure of the study information | 2018/11/07 |
Last modified on | 2024/02/28 14:28:46 |
Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis
Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis
Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis
Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis
Japan |
Knee osteoarthritis
Orthopedics |
Others
NO
The purpose of this study is to investigate the efficacy and safety of autologous cultured cartilage ACC-01 by multicenter, parallel-group clinical trial compared with intra-articular injection of sodium hyaluronate (HA) in patients with knee osteoarthritis.
Efficacy
1) Change in WOMAC score between pre and post treatment with the investigational products
Efficacy
1) Change in WOMAC subscale (pain, stiffness, physical function) between pre and post treatment
2) Change in Lysholm Knee Score (LKS) between pre and post treatment
3) MRI_T2 values
4) 3D MOCART score (MRI evaluation)
5) ICRS score *1 (arthroscopy)
6) Histological evaluation *2
7) Number of days using NSAIDs
8) Presence or absence of repair with hyaline cartilage-like tissues
*1 Patients who give written informed consent of arthroscopy
*2 Patients who give written informed consent of biopsy
Safety
1) Number and rate of adverse events and product-related adverse events
2) Number and rate of significant product-related adverse events
3) Product problem
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Maneuver |
・Taking healthy cartilage tissue
・Transplantation of autologous cultured cartilage ACC-01
Intra-articular injection of sodium hyaluronate
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Patients who are aged 20 years or older at the time of informed consent, and who can give written informed consent
2) Patients having a localized cartilage defect whose size is over 2 cm2
3) Patients diagnosed as osteoarthritis (Kellgren-Lawrence grade 2 or grade 3) by x-ray examination
4) Patients with knee pain
5) Patients who have had conservative therapy, including exercise therapy, for the last 3 months
1) Patients who participated in previous clinical trials of ACC-01, or patients who have undergone ACC-01 transplantation
2) Patients who are aged 75 years or older at the time of informed consent
3) Patients with BMI >= 30
4) Patients who have difficulty in fixation by collagen membrane or periosteum because of entire cartilage defects in the knee joint
5) Patients with severe knee deformation (FTA >=180 degrees, <=170 degrees)
6) Patients who underwent surgery or arthroscopy in the affected knee joint within the last 3 months
7) Patients with a meniscal tear requiring treatment in the affected knee joint, or patients who underwent surgical treatment to meniscal in the affected knee joint in the last 3 months
8) Patients with autoimmune disease (e.g., rheumatoid arthritis), or patients with a history of these diseases
9) Patients with or suspected of a malignancy or patients with a history of malignancy within the last 5 years
10) Patients who have complications in the affected knee joint or whole body and were judged difficult to be evaluated by physicians
11) Patients who have a history of hypersensitivity to antibiotics (gentamicin or amphotericin B), or to aminoglycoside antibiotic
12) Patients with allergy to bovine or swine
13) patient with uncontrolled diabetes
14) Patients with a history of anaphylactic reaction
15) Patients with a history of hypersensitive against atelocollagen
16) Patients who cannot have an MRI examination
17) Patients participating in other clinical trials at the time of consent acquisition and patients planning to participate in other clinical trials during the study participation
18) Pregnant women, lactating women and patients who may be pregnant, or patients who desire pregnancy during clinical studies
19) Patients determined to be inappropriate by physicians
58
1st name | Shigeaki |
Middle name | |
Last name | Hayashi |
Japan Tissue Engineering Co., Ltd.
Clinical Development Dept.
443-0022
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
0533-66-2020
shigeaki_hayashi@jpte.co.jp
1st name | Akira |
Middle name | |
Last name | Sugimoto |
Japan Tissue Engineering Co., Ltd.
Clinical Development Dept.
443-0022
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
0533-66-2020
shigeaki_hayashi@jpte.co.jp
Japan Tissue Engineering Co., Ltd.
None
Self funding
Hiroshima University hospital IRB
Kasumi 1-2-3 Minami-ku,Hiroshima-shi,Hiroshima
082-257-5596
hugcp@hiroshima-u.ac.jp
NO
2018 | Year | 11 | Month | 07 | Day |
Published
https://ssl4.eir-parts.net/doc/7774/tdnet/2403844/00.pdf
58
1.Primary outcomes
It was statistically shown that, in terms of change in WOMAC score between pre and post treatment, ACC-01 group improved significantly compared to HA group. (P<0.0001 Student's t-test)
2.Key secondary outcomes
In ACC-01 group, the number of cartilage defect sites (CDS) was 38 sites, and 37 sites (97.4%) were repaired with hyaline cartilage-like tissue (HCT). In HA group, the number of CDS was 43 sites, and no repair with HCT was observed in any of the CDS.
2024 | Year | 02 | Month | 28 | Day |
In this clinical trial, 58 cases were registered as eligible after screening and as a result of the determination by the Independent Eligibility Committee.
27 of the registered cases were assigned to ACC-01 group. 25 of the transplant cases completed the primary assessment at 52 weeks post treatment. 31 of the registered cases were assigned to HA group, and 29 received doses. The number of FAS cases, which was the primary efficacy analysis set, was 26 in ACC-01 group, and 28 in HA group.
In ACC-01 group, after cartilage slices biopsy and before ACC-01 implantation, 7 adverse events (AE) with a non-negligible causal relationship occurred in 7 cases (25.9%), and 5 AE with a negligible causal relationship occurred in 5 cases (18.5%). All of them were non-serious events.
After implantation, 38 AE with a non-negligible causal relationship occurred in 24 cases (92.3%), and 37 AE with a negligible causal relationship in 18 cases (69.2%). All of them were non-serious events.
In HA group, after the first dose, 2 AE with a non-negligible causal relationship occurred in 1 case (3.4%) and 17 AE with a negligible causal relationship occurred in 11 cases (37.9%). All of them were non-serious events. There were 3 AE in 3 cases that occurred prior to the first dose, all of which were not causally related and non-serious.
1. Primary outcomes
Change in WOMAC score between pre and post treatment with the investigational products
Change in WOMAC score at 52 weeks post treatment with missing values imputed using LOCF was -20.39 (SD 10.09) in ACC-01 group and -5.19 (SD 10.85) in HA group. The group difference in change in WOMAC score was -15.21, and the 95% confidence interval was -20.99~-9.42, indicating that, statistically, ACC-01 group improved significantly compared to HA group (P<0.0001 student's t-test).
2. Key secondary outcomes
1) Change in WOMAC subscale (pain, stiffness, physical function) between pre and post treatment
All subscales in both groups showed an improvement in WOMAC scores over time, with ACC-01 group showing better improvement compared to HA group.
2) Change in Lysholm Knee Score between pre and post treatment
Like the change in the WOMAC score at 52 weeks post treatment for the primary endpoint, ACC-01 group showed better improvement compared to HA group.
3) Number of days using NSAIDs
In ACC-01 group, the number increased up to 12 weeks post treatment but began to decrease after 24 weeks post treatment. In HA group, it was almost constant regardless of the passage of time.
4) Presence or absence of repair with HCT
The presence or absence of repair with HCT was determined by the independent data monitoring committee (IDMC), based on the results of MRIT2 value, the 3D magnetic resonance observation of cartilage repair tissue (MOCART) system, the International Cartilage Repair Society (ICRS) score, and histological evaluation.
The number of CDS in ACC-01 group was 38 in 26 cases. 37 sites (97.4%) in 25 cases were repaired with HCT. On the other hand, 1 site (2.6%) in 1 case showed no repair with HCT.
The number of CDS in HA group was 43 in 27 cases, and no repair with HCT was observed in any of the CDS.
Completed
2018 | Year | 07 | Month | 27 | Day |
2018 | Year | 09 | Month | 18 | Day |
2019 | Year | 04 | Month | 24 | Day |
2023 | Year | 07 | Month | 14 | Day |
2024 | Year | 01 | Month | 16 | Day |
2018 | Year | 11 | Month | 07 | Day |
2024 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039592
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