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OsteochondritisPhase 1/2CS-ACINCT01694823

Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects

A Phase 1/2 study testing CS-ACI in people with Osteochondritis and Osteochondritis Dissecans, run by Yan Jin at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
CS-ACI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesChina
Study dates
Apr 2012to Jun 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female patients, age: between 18 and 50 years
  • Defect: isolated ICRS grade III or IV single defect chondral lesions on Articular Cartilage
  • Defect size: 2.5 to < 5 cm2 after debridement to healthy cartilage up to 6 mm in depth.
  • Nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area
  • Informed consent signed and dated by patient and Patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it
  • No ligament damage or ligament damage after reconstruction

Who cannot join

  • Patients younger than 18 years and older than 50 years.
  • Arthrofibrosis or Ankylosis
  • Arthritis
  • Obesity
  • Infectious diseases
  • the other cases of patients which Doctors determine not participate in the trial

Trial locations and contacts

3 sites in 1 country.

China3 sites, 3 recruiting

  • Xijing Hospital

    Xi'an, 710032

    zhang Chunli, MD, 86-029-84771339, zhangcl816@sohu.com

    zhang chunli, Ph.D

    Recruiting

  • Tangdu Hospital

    Xi'an, 710038

    ding yong, Ph.D, 86-029-84717700, dinyonza@fmmu.edu.cn

    Recruiting

  • Xi'An Honghui Hospital

    Xi'an, 710054

    zheng jiang, 86-0 18802940279, zhengjiang1010@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Open-label Multi-center Study to Demonstrate the Safety and Efficacy of Cells Sheet-Autologous Chondrocyte Implantation（CS-ACI）for the Treatment of Articular Cartilage Defects

In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.

Read the detailed description

All procedures are carried out after obtaining informed written consent from patients. Cartilage tissue is acquired from the Non-weight-bearing area of patients. chondrocyte are isolated and grown in culture for 6-8 weeks. After this time interval, the cells are reprocessed and the cell sheet is obtained. Implantation of the chondrocyte sheet into the Cartilage defect of the keen.The patients will be assessed clinically with scoring systems preoperatively as well as 24 months postoperatively to assess relief of symptoms and joint function. Radiological assessment (MRIs)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. Second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the International Cartilage Repair Society guidelines.

Being tested
CS-ACI
Keywords
Cartilage repair, Cartilage defects, cell sheet, Autologous chondrocyte implantation
Medical subject headings
Osteochondritis, Osteochondritis Dissecans, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CS-ACIDrug

    Also called Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）

    Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names:

    Cells Sheet-Autologous Chondrocyte Implantation （CS-ACI）

Study groups in NCT01694823
Study groupRoleWhat they receive
CS-ACIExperimentalGroup/Cohort Label： pretherapy post-treatment Group/Cohort Description ：The CS-ACI is used to prepare cell sheet and implant to the Cartilage defects.The arm of safety and efficacy are compared preoperative observation with postoperative observation.
Receives: Drug: CS-ACI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in the MRI

    Measured: 3month,6 month, 12 months, 24 months

Secondary outcomes (2)

  1. Change from Baseline in the Lysholm

    Measured: 3month,6 month, 12 months, 24 months

  2. Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport

    Measured: 3month,6 month, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJul 2013 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01694823
Sponsor's protocol ID
CS-ACI2012001
Acronym
CS-ACI
Status last verified
Sep 2012
First submitted
24 Sep 2012
Last updated
1 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Ebihara G, Sato M, Yamato M, Mitani G, Kutsuna T, Nagai T, Ito S, Ukai T, Kobayashi M, Kokubo M, Okano T, Mochida J. Cartilage repair in transplanted scaffold-free chondrocyte sheets using a minipig model. Biomaterials. 2012 May;33(15):3846-51. doi: 10.1016/j.biomaterials.2012.01.056. Epub 2012 Feb 25.

    PubMed 22369960

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CS-ACI in people with Osteochondritis and Osteochondritis Dissecans, run by Yan Jin at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in the MRI (time frame: 3month,6 month, 12 months, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01694823, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.

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