Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

December 10, 2015 updated by: Banc de Sang i Teixits

Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08022
        • Centro Medico Teknon-ITRT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients < 18 years or legally dependent
  2. Patients >65 years
  3. Previous surgery of the knee
  4. Intraarticular treatment in the past 6 month
  5. Knee ligament or meniscus rupture observed by MRI
  6. Any sign of infection
  7. Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
  8. Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
  9. Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
  10. Pregnant women or intend to become pregnant or breast-feeding
  11. Neoplasia
  12. Immunosuppressive states
  13. Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
  14. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous MSC knee implantation
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
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 Names:
  • Xcel-m-condro-alpha

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
Time Frame: 12 months
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.
Time Frame: 12 months
Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy by imaging procedures.
Time Frame: 6 months
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
6 months
Efficacy by imaging procedures.
Time Frame: 12 month
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
12 month
Clinical outcomes.
Time Frame: 3 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).
3 month
Clinical outcomes.
Time Frame: 6 months
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).
6 months
Clinical outcomes.
Time Frame: 12 months
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banc de Sang i Teixits

Collaborators

Centro Medico Teknon
Institut de Terapia Regenerativa Tissular
Cetir Sant Jordi, S.a..

Investigators

  • Principal Investigator: Robert Soler, MD, Institut de Teràpia Regenerativa Tissular (ITRT)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCEL-M-09-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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