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Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

Primary Purpose

Osteoarthritis, Knee, Knee Injuries, Joint Diseases

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Autologous MSC knee implantation
Sponsored by
Banc de Sang i Teixits
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Cell therapy, Regenerative therapy, Advance therapy, Bone marrow, Mesenchymal stem cell, Autologous, Interventional clinical trial, Osteoarthrosis, Osteoarthritis, Knee

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Medico Teknon-ITRT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous MSC knee implantation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Efficacy by imaging procedures.
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
Efficacy by imaging procedures.
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
Clinical outcomes.
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).
Clinical outcomes.
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).
Clinical outcomes.
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).

Full Information

First Posted
October 22, 2010
Last Updated
December 10, 2015
Sponsor
Banc de Sang i Teixits
Collaborators
Centro Medico Teknon, Institut de Terapia Regenerativa Tissular, Cetir Sant Jordi, S.a..
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1. Study Identification

Unique Protocol Identification Number
NCT01227694
Brief Title
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis
Official Title
Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
Centro Medico Teknon, Institut de Terapia Regenerativa Tissular, Cetir Sant Jordi, S.a..

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Knee Injuries, Joint Diseases, Rheumatic Diseases, Cartilage Diseases
Keywords
Cell therapy, Regenerative therapy, Advance therapy, Bone marrow, Mesenchymal stem cell, Autologous, Interventional clinical trial, Osteoarthrosis, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous MSC knee implantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Autologous MSC knee implantation
Other Intervention Name(s)
Xcel-m-condro-alpha
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
Description
Feasibility will be assessed by checking the cascade of procedures (from bone marrow extraction to MSC implantation) and confirming the global process is viable.
Time Frame
12 months
Title
Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
Description
Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy by imaging procedures.
Description
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
Time Frame
6 months
Title
Efficacy by imaging procedures.
Description
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
Time Frame
12 month
Title
Clinical outcomes.
Description
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).
Time Frame
3 month
Title
Clinical outcomes.
Description
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).
Time Frame
6 months
Title
Clinical outcomes.
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Soler, MD
Organizational Affiliation
Institut de Teràpia Regenerativa Tissular (ITRT)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Teknon-ITRT
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25769789
Citation
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.
Results Reference
derived
Links:
URL
http://www.itrt.es
Description
Institut de Terapia Regenerativa Tissular (ITRT), Barcelona, Spain
URL
http://www.bancsang.net
Description
Banc de Sang i Teixits

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Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

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