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Clinical Trials/EUCTR2011-005321-51-ES
EUCTR2011-005321-51-ES
Active, not recruiting
Not Applicable

Treatment of osteoarthritis with allogeneic mesenchymal cells (MSV *). - Treatment of osteoarthritis with allogeneic mesenchymal cells (MSV *).

Parque Científico de la Universidad de Valladolid0 sites30 target enrollmentNovember 22, 2011
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Conditionsgonarthrosis (osteoarthritis)MedDRA version: 14.1Level: LLTClassification code 10048794Term: GonarthrosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Drugscélulas mesenquimales estromales de médula ósea obtenidas de donantes sanos con serología negativa/MSV/Suspension for injectionDurolane

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
gonarthrosis (osteoarthritis)
Sponsor
Parque Científico de la Universidad de Valladolid
Enrollment
30
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 22, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Parque Científico de la Universidad de Valladolid

Eligibility Criteria

Inclusion Criteria

  • •1\. Gonarthrosis grade 2, 3 or 4 of Kellgren and Lawrence (Kellgren \& Lawrence, 1957\) assessed by two observers.
  • •2\. Chronic painful knee mechanical properties.
  • •3\. No local or systemic septic process.
  • •4\. Hematological and biochemical analysis without significant alterations that contraindicate treatment.
  • •5\. Written informed consent of the patient.
  • •6\. The patient is able to understand the nature of the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 30

Exclusion Criteria

  • •1\. Patient \<18 years, or legally dependent
  • •2\. Patient\> 65 years
  • •3\. Affected knee prior involvement in
  • •4\. Intraarticular treatment in the last 6 months.
  • •5\. Ligament disruption MRI image displayed on
  • •6\. Infection present (for inclusion in the study should not evidenced any sign infectious).
  • •7\. Congenital malformations or evolutionary translate and / or significant deformation of the knee and condition difficulties of implementation and evaluation of results.
  • •8\. Excess weight expressed as body mass index (BMI) 30\.5 (obesity class II). As BMI \= weight (kg): (height (m)) 2
  • •9\. Women who are pregnant or intend to become pregnant, or breastfeeding
  • •10\. neoplastic disease

Outcomes

Primary Outcomes

Not specified

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