Autologous Mesenchymal Stem Cells vs. Chondrocytes for the Repair of Chondral Knee Defects (ASCROD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier:
NCT01399749
First received: July 20, 2011
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Articular Cartilage Lesion of the Femoral Condyle
Other: Implantation of autologous cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:

Primary Outcome Measures:
  • Hyaline cartilage production for chondral knee lesions repair [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Clinical evolution [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Changes in Clinical tests and SF-12 Health Survey over 18 months

  • Efficacy: Functional evolution [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Changes in Western Ontario-McMaster Osteoarthritis Score(WOMAC) over 18 months

  • Efficacy: Functional evolution [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Changes in Knee Society Score(KSS) over 18 months

  • Efficacy: Histological evaluation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Hyaline cartilage production by histological methods at 18 months

  • Efficacy: Radiological evaluation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    MRI at 18 months

  • Safety: Adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Sistemic and local AEs especially attributable to implanted cells

  • Safety: Acute inflammatory events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous ASC implantation
Treatment with autologous ASC
Other: Implantation of autologous cells
Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane
Other Name: ACI
Active Comparator: Autologous Chondrocytes implantation
Treatment with autologous chondrocytes
Other: Implantation of autologous cells
Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane
Other Name: ACI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399749

Contacts
Contact: Alonso C. Moreno Garcia, MD +34 917277314 alonso.moreno.garcia@gmail.com
Contact: Fernando de Miguel +34 912071022 fdemiguel.hulp@salud.madrid.org

Locations
Spain
La Paz University Hospital. Orthopedic Surgery and Traumatology Department, Knee Unit; Cell Therapy Laboratory. Not yet recruiting
Madrid, Spain, 28046
Principal Investigator: Alonso C. Moreno Garcia, MD         
Sub-Investigator: Jose L. Leal Helmling, MD         
Sub-Investigator: Santiago Bello, MD         
Sub-Investigator: Fernando de Miguel, PhD         
Sub-Investigator: Damian Garcia-Olmo, MD         
Sub-Investigator: Mariano A. Garcia-Arranz, PhD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Investigators
Principal Investigator: Alonso C. Moreno Garcia, MD Orthopedic Surgery and Traumatology Department. Knee Unit
  More Information

Publications:
Responsible Party: Alonso C. Moreno Garcia, La Paz University Hospital. Orthopedic Surgery and Traumatology Department
ClinicalTrials.gov Identifier: NCT01399749     History of Changes
Other Study ID Numbers: HLPTRA-2009-01, 2009-016628-29
Study First Received: July 20, 2011
Last Updated: July 21, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
Cartilage
Articular
Femoral
Knee
Chondrocytes
Adipose tissue-derived mesenchymal stem cells

ClinicalTrials.gov processed this record on October 30, 2014