NCT01399749

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

July 20, 2011

Last Update Submit

July 21, 2011

Conditions

Articular Cartilage Lesion of the Femoral Condyle

Keywords

CartilageArticularFemoralKneeChondrocytesAdipose tissue-derived mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

  • Hyaline cartilage production for chondral knee lesions repair

    18 months

Secondary Outcomes (7)

  • Efficacy: Clinical evolution

    18 months

  • Efficacy: Functional evolution

    18 months

  • Efficacy: Functional evolution

    18 months

  • Efficacy: Histological evaluation

    18 months

  • Efficacy: Radiological evaluation

    18 months

  • +2 more secondary outcomes

Study Arms (2)

Autologous ASC implantation

EXPERIMENTAL

Treatment with autologous ASC

Other: Implantation of autologous cells

Autologous Chondrocytes implantation

ACTIVE COMPARATOR

Treatment with autologous chondrocytes

Other: Implantation of autologous cells

Interventions

Implantation of autologous cellsOTHER

Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane

Also known as: ACI
Autologous ASC implantationAutologous Chondrocytes implantation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Paz University Hospital. Orthopedic Surgery and Traumatology Department, Knee Unit; Cell Therapy Laboratory.

Madrid, Madrid, 28046, Spain

Location

Related Publications (3)

  • 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.

    PMID: 8078550BACKGROUND

  • Wakitani 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.

    PMID: 11869080BACKGROUND

  • Garcia-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.

    PMID: 20831449BACKGROUND

Study Officials

  • Alonso C. Moreno Garcia, MD

    Orthopedic Surgery and Traumatology Department. Knee Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alonso C. Moreno Garcia, MD

CONTACT

+34 917277314alonso.moreno.garcia@gmail.com

Fernando de Miguel

CONTACT

+34 912071022fdemiguel.hulp@salud.madrid.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 22, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

ES(1)