Unique ID issued by UMIN | UMIN000035151 |
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Receipt number | R000039049 |
Scientific Title | Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint |
Date of disclosure of the study information | 2018/12/10 |
Last modified on | 2024/01/04 17:20:36 |
Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Japan |
Focal cartilage defect of the knee joint caused by trauma and/or early osteoarthritis
Orthopedics |
Others
NO
The objective of this study is to evaluate the safety and study evaluation criteria for a focal cartilage defect repair of the knee joint caused by trauma and/or early osteoarthritis using minimally invasive transplantation of autologous chondrocytes products (ACP).
Safety,Efficacy
Exploratory
Phase I
Clinical evaluation (Improvement of KOOS (Knee injury and Osteoarthritis Outcome Score) from baseline)
Clinical evaluation, MRl, Arthroscopy, Pathological evaluation and Activity evaluation. Frequency and content of adverse events.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Chondrocytes are obtained from unloaded part of patient's cartilage and cultured through passaging. The chondrocytes mixed with hydrogel are transplanted under arthroscopy or minimal open surgery.
16 | years-old | <= |
Not applicable |
Male and Female
Patients with symptomatic pain of the knee who has focal chondral defect detectable by MRI.
Patients with chondral defect of ICRS III/IV or Outerbridge-Brittberg III/IV.
The size of chondral defect:2-9cm2.
Patients with
1.advanced osteoarthritis KL grade II and above with narrowing of the gap of knee joint,
2.arthritis with autoimmune disease such as Rheumatoid arthritis,
3.abnormal alignment of lower extremity,
4.infectious disease (HIV/HBV/HCV/HTLV etc.).
6
1st name | Ken |
Middle name | |
Last name | Nakata |
Osaka University Graduate School of Medicine
Medicine for Sports and Performing Arts
565-0871
2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
0662108439
takanamoto@hss.osaka-u.ac.jp
1st name | Takashi |
Middle name | |
Last name | Kanamoto |
Osaka University Graduate School of Medicine
Medicine for Sports and Performing Arts
565-0871
2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
0662108439
takanamoto@hss.osaka-u.ac.jp
Department of Orthopaedics, Osaka University
Graduate School of Medicine
Interstem Co., Ltd.
Profit organization
Department of Orthopaedics, Osaka University Graduate School of Medicine
2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
0662108439
takanamoto@hss.osaka-u.ac.jp
YES
jRCTb050190105
Japan Registry of Clinical Trials
2018 | Year | 12 | Month | 10 | Day |
https://jrct.niph.go.jp/latest-detail/jRCTb050190105
Published
https://jrct.niph.go.jp/latest-detail/jRCTb050190105
6
In 6 patients who underwent ACP, there were 11 adverse events, but none were serious.
The primary endpoint, the change from baseline in KOOS 5 at Week 52, showed significant improvement, and ACP can be estimated to be effective.
The secondary endpoints KOOS-symptoms and KOOS-pain showed significant improvement from baseline, with an improvement in scores above the MCID on the average of all five items.
Based on the mean of 14 ICRSII items, it was determined that an estimate of efficacy could be made.
2024 | Year | 01 | Month | 04 | Day |
The six patients who were deemed eligible for cell transplantation in this study and enrolled in the secondary enrollment consisted of four males (66.7%) and two females (33.3%), who were 52.8 plus (or) minus 7.5 years old at the time consent was obtained.
The primary disease was early osteoarthritis of the knee in 5 patients (83.3%) and other (right knee PF articular cartilage damage) in 1 patient (16.7%). 3 patients (50.0%) had right-sided and 3 patients (50.0%) had left-sided knees, and none of them received surgical treatment or physical therapy related to this treatment.
Consent was obtained from 8 patients and screening tests were performed.
Two cases did not reach secondary enrollment.
One was considered ineligible before the secondary enrollment because the patient did not meet the inclusion criteria, and one was considered ineligible before the first enrollment because the patient did not meet the exclusion criteria.
There were six patients who underwent autologous cultured chondrocyte transplantation(ACP) after secondary enrollment, all of whom completed the 52-week observation period specified for this study.
One of 6 patients was last observed at 130 weeks after transplantation because the patient requested to refrain from visiting the clinic due to concerns about COVID-19 infection resulting from the visit, following the spread of COVID-19 infection after the 26-week postoperative visit.
Eleven cell transplantation related adverse events occurred in all six patients treated with this therapy.
There were no cases of infections suspected to have been caused by the provision of regenerative medicine.
Two adverse events that were considered to have a direct causal relationship to this treatment, autologous chondrocyte transplantation, were partial cartilage loss and cartilage hyperplasia in one patient.
Other nine adverse events judged to be weakly related to this treatment included six cases of postoperative pain, one case of left plantar numbness, two cases of postoperative swelling.
The change from baseline (at screening) in KOOS 5 at 52 weeks, the primary efficacy endpoint, was showing a marked improvement.
The MCID (Minimal Clinically Important Difference, clinically relevant minimum change) of the KOOS subscore used as a secondary efficacy endpoint was 8 -10, and of the five items, KOOS-symptoms and KOOS-pain were recognized as notable improvements from the time of screening, and all five items showed improvements in scores above the MCID on average.
Completed
2018 | Year | 10 | Month | 30 | Day |
2018 | Year | 10 | Month | 30 | Day |
2019 | Year | 02 | Month | 14 | Day |
2022 | Year | 09 | Month | 30 | Day |
2018 | Year | 12 | Month | 06 | Day |
2024 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039049
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