Tear; Knee, Cartilage, ArticularPhase 1/2NCT01503970
Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration
A Phase 1/2 study testing Arthroscopic matrix encapsulated chondrocyte implantation in people with Tear; Knee, Cartilage, Articular, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
Trial summary
The purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and MRI outcomes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Tear; Knee, Cartilage, Articular
- What is being tested?
- Arthroscopic matrix encapsulated chondrocyte implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2008to Dec 2012
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with symptomatic chondral lesions of the knee
Who cannot join
- Inflammatory arthritis
- Septic arthritis
- Total meniscectomy
- Previous microfracture at chondral lesions
- Paget
- Ochronosis
- Acromegalia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study
The purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and MRI outcomes.
Read the detailed description
Injuries to the articular cartilage of the knee are common. They produce pain and deteriotation of patients' quality of life. The management of focal chondral lesions continues to be problematic for the treating orthopaedic surgeon. Although many treatment options are currently available, none fulfill the criteria for an ideal repair solution: a hyaline repair tissue that completely fills the defect and integrates well with the surrounding normal cartilage. Autologous chondrocyte implantation is a relatively new cell-based treatment method for full-thickness cartilage injuries that in recent years has increased in popularity, with different studies showing promising results. Typically, this implantation is performed in an open-surgery fashion. In our study the implantation of in-house autologous chondrocyte culture is done arthroscopically, situation that may offer advantages in surgery associated morbidity and patient recovery.
- Conditions
- Tear; Knee, Cartilage, Articular
- Being tested
- Arthroscopic matrix encapsulated chondrocyte implantation
- Keywords
- chondral lesions, knee
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic matrix encapsulated chondrocyte implantationDevice
Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.
| Study group | Role | What they receive |
|---|---|---|
| Chondrocyte implantation | Experimental | Not described Receives: Device: Arthroscopic matrix encapsulated chondrocyte implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.
Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds.
Measured: 3, 6, 9, 12, 18, 24 36 months
Secondary outcomes (1)
Change of baseline to different periods in Clinical evaluation
Clinical assessment with validated knee scores, and adverse effects register are taken.
Measured: 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startDec 2008
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tear; Knee, Cartilage, ArticularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Aldo Izaguirre, Instituto Nacional de Rehabilitacion
- Investigators
- Clemente Ibarra, M.D., Principal investigator, INRLuis Guillermo Ibarra, M.D., Study chair, INRAldo F Izaguirre, M.D., Study director, INREnrique Villalobos, M.D., Study director, INR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503970
- Sponsor's protocol ID
- 017-04-INR
- Status last verified
- Apr 2017
- First submitted
- 1 Dec 2011
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Masri M, Lombardero G, Velasquillo C, Martinez V, Neri R, Villegas H, Ibarra C. Matrix-encapsulation cell-seeding technique to prevent cell detachment during arthroscopic implantation of matrix-induced autologous chondrocytes. Arthroscopy. 2007 Aug;23(8):877-83. doi: 10.1016/j.arthro.2007.05.010.
PubMed 17681210Ibarra-Ponce de Leon JC, Velasquillo-Martinez MC, Izaguirre A, Villalobos-Cordova E, Masri M, Ibarra-Ibarra LG. [Cartilage repair: cell-based techniques]. Acta Ortop Mex. 2009 Jan-Feb;23(1):38-44. Spanish.
PubMed 19462773Ibarra C, Izaguirre A, Villalobos E, Masri M, Lombardero G, Martinez V, Velasquillo C, Meza AO, Guevara V, Ibarra LG. Follow-up of a new arthroscopic technique for implantation of matrix-encapsulated autologous chondrocytes in the knee. Arthroscopy. 2014 Jun;30(6):715-23. doi: 10.1016/j.arthro.2014.02.032. Epub 2014 Apr 18.
PubMed 24746406
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study
- ClinicalTrials.gov ID
- NCT01503970
- Acronym / sponsor ID
- 017-04-INR
- Conditions
- Tear; Knee, Cartilage, Articular
- Keywords
- chondral lesions, knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and MRI outcomes.
Detailed description
Injuries to the articular cartilage of the knee are common. They produce pain and deteriotation of patients' quality of life. The management of focal chondral lesions continues to be problematic for the treating orthopaedic surgeon. Although many treatment options are currently available, none fulfill the criteria for an ideal repair solution: a hyaline repair tissue that completely fills the defect and integrates well with the surrounding normal cartilage. Autologous chondrocyte implantation is a relatively new cell-based treatment method for full-thickness cartilage injuries that in recent years has increased in popularity, with different studies showing promising results. Typically, this implantation is performed in an open-surgery fashion. In our study the implantation of in-house autologous chondrocyte culture is done arthroscopically, situation that may offer advantages in surgery associated morbidity and patient recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chondrocyte implantation | Experimental | Device: Arthroscopic matrix encapsulated chondrocyte implantation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with symptomatic chondral lesions of the knee
Key exclusion criteria (7 listed)
- Inflammatory arthritis
- Septic arthritis
- Total meniscectomy
- Previous microfracture at chondral lesions
- Paget
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic matrix encapsulated chondrocyte implantationEach implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect. | Device | Chondrocyte implantation |
Primary outcome
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.
Time frame: 3, 6, 9, 12, 18, 24 36 months
Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds.
1 secondary outcome
Change of baseline to different periods in Clinical evaluation
Time frame: 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Background: PubMed 17681210Masri M, Lombardero G, Velasquillo C, Martinez V, Neri R, Villegas H, Ibarra C. Matrix-encapsulation cell-seeding technique to prevent cell detachment during arthroscopic implantation of matrix-induced autologous chondrocytes. Arthroscopy. 2007 Aug;23(8):877-83. doi: 10.1016/j.arthro.2007.05.010.
- Background: PubMed 19462773Ibarra-Ponce de Leon JC, Velasquillo-Martinez MC, Izaguirre A, Villalobos-Cordova E, Masri M, Ibarra-Ibarra LG. [Cartilage repair: cell-based techniques]. Acta Ortop Mex. 2009 Jan-Feb;23(1):38-44. Spanish.
- Background: PubMed 24746406Ibarra C, Izaguirre A, Villalobos E, Masri M, Lombardero G, Martinez V, Velasquillo C, Meza AO, Guevara V, Ibarra LG. Follow-up of a new arthroscopic technique for implantation of matrix-encapsulated autologous chondrocytes in the knee. Arthroscopy. 2014 Jun;30(6):715-23. doi: 10.1016/j.arthro.2014.02.032. Epub 2014 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemente Ibarra, M.D. principal investigator
INR
Luis Guillermo Ibarra, M.D. study chair
INR
Aldo F Izaguirre, M.D. study director
INR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arthroscopic matrix encapsulated chondrocyte implantation in people with Tear; Knee, Cartilage, Articular, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment. (time frame: 3, 6, 9, 12, 18, 24 36 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 NCT01503970, which also lists 3 linked publications.
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 12 Apr 2017.