Articular Cartilage Lesion of the Femoral CondylePhase 1/2ASCRODNCT01399749
Autologous Mesenchymal Stem Cells vs. Chondrocytes for the Repair of Chondral Knee Defects
A Phase 1/2 study testing Implantation of autologous cells in people with Articular Cartilage Lesion of the Femoral Condyle, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
Trial summary
The objective of our study is to compare the safety and effectiveness of the use of autologous cultured adipose tissue-derived stem cells versus cultured autologous chondrocytes for the treatment of chondral knee lesions. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Articular Cartilage Lesion of the Femoral Condyle
- What is being tested?
- Implantation of autologous cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Jun 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic focal articular cartilage lesion on the medial femoral condyle
- Lesion on femoral condyle between 1 and 5 cm²
- ICRS Grade III/IV
- Stable knee
- Signed patient informed consent
Who cannot join
- Clinically relevant member malalignment (> 5 degrees)
- Non stable knee
- Inflammatory joint disease
- Knee surgery in the last year (transplant, suture or resection of the meniscus, mosaicplasty, microfracture)
- Participation in concurrent trials or in the previous 3 months
- Subjects with hepatitis, HIV or syphilis
Show all 21Show fewer
- Malignancy in the previous 5 years
- Alcohol and/or drug abuse
- Poor general health as judged by Investigator
- Clinically relevant second cartilage lesion on the patella
- Patellofemoral cartilage lesion
- Known allergy to gentamicin or penicillins (or presence of multiple severe allergies)
- Having received hyaluronic acid intra-articular injections in the affected knee within the last 6 months of baseline
- Taking specific OA drugs such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of the baseline visit
- Corticosteroid treatment by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroids within the last 2 weeks of baseline
- Chronic use of anticoagulants
- Uncontrolled diabetes
- Any concomitant painful or disabling disease of the spine,hips or lower limbs that would interfere with evaluation of the afflicted knee
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more then two times the upper limit of normal or any other result that is clinically important according to the Investigator
- CRP > 10 mg/l
Trial locations and contacts
1 site in 1 country.
Spain1 site
La Paz University Hospital. Orthopedic Surgery and Traumatology Department, Knee Unit; Cell Therapy Laboratory.
Madrid, Madrid, 28046
Alonso C. Moreno Garcia, MD
Jose L. Leal Helmling, MD
About this study
Official title: A Comparative Clinical Trial for the Repair of Chondral Knee Defects: Transplantation of Autologous Cultured Chondrocytes vs. Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
The objective of our study is to compare the safety and effectiveness of the use of autologous cultured adipose tissue-derived stem cells versus cultured autologous chondrocytes for the treatment of chondral knee lesions.
Read the detailed description
Chondral knee lesions are frequent and produce important functional limitations and arthrosis development. Arthrosis is one of the most important causes of disability and its treatment with prosthetic surgery is associated with a high cost, and is not free of other complications. Several studies of cell therapy with autologous chondrocytes have shown efficacy in the treatment of this type of lesions, and currently is a common technique for the treatment of focal lesions of articular cartilage. Autologous chondrocyte transplant is associated with morbidity of the cartilage sample removal, which needs intra-articular surgery, and the limited tissue sample for culture. Adipose tissue-derived mesenchymal stem cells (ASC) have demonstrated chondrocytic differentiation and have been used in animal models for articular cartilage repair. Adipose tissue yields more ASC than chondrocytes are obtained from cartilage, and liposuction is simple and with less adverse events than arthroscopy. It is worth mentioned that culture conditions are less stringent for ASC than for chondrocytes, in terms of number of passages to obtain the amount of cells needed for implantation.
We propose a randomized clinical trial, in which we compare the surgical implantation of either autologous chondrocytes or autologous ASC to treat chondral knee lesions.
- Being tested
- Implantation of autologous cells
- Keywords
- Cartilage, Articular, Femoral, Knee, Chondrocytes, Adipose tissue-derived mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of autologous cellsOther
Also called ACI
Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane
| Study group | Role | What they receive |
|---|---|---|
| Autologous ASC implantation | Experimental | Treatment with autologous ASC Receives: Other: Implantation of autologous cells |
| Autologous Chondrocytes implantation | Active comparator | Treatment with autologous chondrocytes Receives: Other: Implantation of autologous cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyaline cartilage production for chondral knee lesions repair
Measured: 18 months
Secondary outcomes (7)
Efficacy: Clinical evolution
Changes in Clinical tests and SF-12 Health Survey over 18 months
Measured: 18 months
Efficacy: Functional evolution
Changes in Western Ontario-McMaster Osteoarthritis Score(WOMAC) over 18 months
Measured: 18 months
Efficacy: Functional evolution
Changes in Knee Society Score(KSS) over 18 months
Measured: 18 months
Efficacy: Histological evaluation
Hyaline cartilage production by histological methods at 18 months
Measured: 18 months
Efficacy: Radiological evaluation
MRI at 18 months
Measured: 18 months
Safety: Adverse events
Sistemic and local AEs especially attributable to implanted cells
Measured: 18 months
Safety: Acute inflammatory events
Increase of pain of at least 30 mm on a 100 mm visual analog scale (VAS) along with self-reported swelling within 3 days post-cell application
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
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 Articular Cartilage Lesion of the Femoral CondyleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Sponsor type
- University, hospital or other
- Investigators
- Alonso C. Moreno Garcia, MD, Principal investigator, Orthopedic Surgery and Traumatology Department. Knee Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399749
- Sponsor's protocol ID
- HLPTRA-2009-01
- Other IDs
- 2009-016628-29, 2009
- Acronym
- ASCROD
- Status last verified
- Jul 2011
- First submitted
- 20 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994 Oct 6;331(14):889-95. doi: 10.1056/NEJM199410063311401.
PubMed 8078550Wakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. doi: 10.1053/joca.2001.0504.
PubMed 11869080Garcia-Gomez I, Elvira G, Zapata AG, Lamana ML, Ramirez M, Castro JG, Arranz MG, Vicente A, Bueren J, Garcia-Olmo D. Mesenchymal stem cells: biological properties and clinical applications. Expert Opin Biol Ther. 2010 Oct;10(10):1453-68. doi: 10.1517/14712598.2010.519333.
PubMed 20831449
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Trial for the Repair of Chondral Knee Defects: Transplantation of Autologous Cultured Chondrocytes vs. Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
- ClinicalTrials.gov ID
- NCT01399749
- Acronym / sponsor ID
- ASCROD / HLPTRA-2009-01
- Keywords
- Cartilage, Articular, Femoral, Knee, Chondrocytes, Adipose tissue-derived mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la PazUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 22 Jul 2011 (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 objective of our study is to compare the safety and effectiveness of the use of autologous cultured adipose tissue-derived stem cells versus cultured autologous chondrocytes for the treatment of chondral knee lesions.
Detailed description
Chondral knee lesions are frequent and produce important functional limitations and arthrosis development. Arthrosis is one of the most important causes of disability and its treatment with prosthetic surgery is associated with a high cost, and is not free of other complications. Several studies of cell therapy with autologous chondrocytes have shown efficacy in the treatment of this type of lesions, and currently is a common technique for the treatment of focal lesions of articular cartilage. Autologous chondrocyte transplant is associated with morbidity of the cartilage sample removal, which needs intra-articular surgery, and the limited tissue sample for culture. Adipose tissue-derived mesenchymal stem cells (ASC) have demonstrated chondrocytic differentiation and have been used in animal models for articular cartilage repair. Adipose tissue yields more ASC than chondrocytes are obtained from cartilage, and liposuction is simple and with less adverse events than arthroscopy. It is worth mentioned that culture conditions are less stringent for ASC than for chondrocytes, in terms of number of passages to obtain the amount of cells needed for implantation.
We propose a randomized clinical trial, in which we compare the surgical implantation of either autologous chondrocytes or autologous ASC to treat chondral knee lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous ASC implantation | Experimental | Other: Implantation of autologous cellsTreatment with autologous ASC |
| Autologous Chondrocytes implantation | Active comparator | Other: Implantation of autologous cellsTreatment with autologous chondrocytes |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Symptomatic focal articular cartilage lesion on the medial femoral condyle
- Lesion on femoral condyle between 1 and 5 cm²
- ICRS Grade III/IV
- Stable knee
- Signed patient informed consent
Key exclusion criteria (21 listed)
- Clinically relevant member malalignment (> 5 degrees)
- Non stable knee
- Inflammatory joint disease
- Knee surgery in the last year (transplant, suture or resection of the meniscus, mosaicplasty, microfracture)
- Participation in concurrent trials or in the previous 3 months
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 |
|---|---|---|
| Implantation of autologous cellsAlso: ACIImplantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane | Other | Autologous ASC implantation, Autologous Chondrocytes implantation |
Primary outcome
Hyaline cartilage production for chondral knee lesions repair
Time frame: 18 months
7 secondary outcomes
Efficacy: Clinical evolution
Time frame: 18 months
Efficacy: Functional evolution
Time frame: 18 months
Efficacy: Functional evolution
Time frame: 18 months
Efficacy: Histological evaluation
Time frame: 18 months
Efficacy: Radiological evaluation
Time frame: 18 months
Safety: Adverse events
Time frame: 18 months
Safety: Acute inflammatory events
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Background: PubMed 8078550Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994 Oct 6;331(14):889-95. doi: 10.1056/NEJM199410063311401.
- Background: PubMed 11869080Wakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. doi: 10.1053/joca.2001.0504.
- Background: PubMed 20831449Garcia-Gomez I, Elvira G, Zapata AG, Lamana ML, Ramirez M, Castro JG, Arranz MG, Vicente A, Bueren J, Garcia-Olmo D. Mesenchymal stem cells: biological properties and clinical applications. Expert Opin Biol Ther. 2010 Oct;10(10):1453-68. doi: 10.1517/14712598.2010.519333.
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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.
Alonso C. Moreno Garcia, MD principal investigator
Orthopedic Surgery and Traumatology Department. Knee Unit
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 Implantation of autologous cells in people with Articular Cartilage Lesion of the Femoral Condyle, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
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 5 inclusion and 21 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 22 Jul 2011. 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 Spain. 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?
Contact Alonso C. Moreno Garcia, MD (+34 917277314, alonso.moreno.garcia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyaline cartilage production for chondral knee lesions repair (time frame: 18 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 NCT01399749, 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 22 Jul 2011.