NCT01227694

Brief Summary

This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires. MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month. The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 11, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

October 22, 2010

Last Update Submit

December 10, 2015

Conditions

Osteoarthritis, KneeKnee InjuriesJoint DiseasesRheumatic DiseasesCartilage Diseases

Keywords

Cell therapyRegenerative therapyAdvance therapyBone marrowMesenchymal stem cellAutologousInterventional clinical trialOsteoarthrosisOsteoarthritisKnee

Outcome Measures

Primary Outcomes (2)

  • Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.

    Feasibility will be assessed by checking the cascade of procedures (from bone marrow extraction to MSC implantation) and confirming the global process is viable.

    12 months

  • Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.

    Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months.

    12 months

Secondary Outcomes (5)

  • Efficacy by imaging procedures.

    6 months

  • Efficacy by imaging procedures.

    12 month

  • Clinical outcomes.

    3 month

  • Clinical outcomes.

    6 months

  • Clinical outcomes.

    12 months

Study Arms (1)

Autologous MSC knee implantation

EXPERIMENTAL

Isolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias Avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection.

Other: Autologous MSC knee implantation

Interventions

Autologous MSC knee implantationOTHER

Isolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection.

Also known as: Xcel-m-condro-alpha
Autologous MSC knee implantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
  • Chronic knee pain with mechanical characteristics
  • Absence of local or systemic septic process
  • Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
  • Informed Consent form signed by the patient
  • The patient is able to understand the nature of the study

You may not qualify if:

  • Patients \< 18 years or legally dependent
  • Patients \>65 years
  • Previous surgery of the knee
  • Intraarticular treatment in the past 6 month
  • Knee ligament or meniscus rupture observed by MRI
  • Any sign of infection
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
  • Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
  • Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
  • Pregnant women or intend to become pregnant or breast-feeding
  • Neoplasia
  • Immunosuppressive states
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Medico Teknon-ITRT

Barcelona, 08022, Spain

Location

Related Publications (1)

  • Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.

    PMID: 25769789DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeKnee InjuriesJoint DiseasesRheumatic DiseasesCartilage DiseasesOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesLeg InjuriesWounds and InjuriesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert Soler, MD

    Institut de Teràpia Regenerativa Tissular (ITRT)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

January 1, 2013

Last Updated

December 11, 2015

Record last verified: 2015-11

Locations

ES(1)