Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee Knee Injuries Joint Diseases Rheumatic Diseases Cartilage Diseases	Other: Autologous MSC knee implantation	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.

Resource links provided by NLM:

MedlinePlus related topics: Cartilage Disorders Joint Disorders Knee Injuries and Disorders Osteoarthritis

U.S. FDA Resources

Further study details as provided by Banc de Sang i Teixits:

Primary Outcome Measures:

Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
Efficacy by imaging procedures. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).
Clinical outcomes. [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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).

Estimated Enrollment:	15
Study Start Date:	October 2010
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Xcel-m-condro-alpha

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227694

Locations

Spain
Centro Medico Teknon-ITRT
Barcelona, Spain, 08022

Sponsors and Collaborators

Banc de Sang i Teixits

Centro Medico Teknon

Institut de Terapia Regenerativa Tissular

CETIR Sant Jordi, Barcelona, Spain

Investigators

Principal Investigator:

Robert Soler, MD

Institut de Teràpia Regenerativa Tissular (ITRT)

More Information

Additional Information:

Institut de Terapia Regenerativa Tissular (ITRT), Barcelona, Spain This link exits the ClinicalTrials.gov site

Banc de Sang i Teixits This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Joan Garcia, MD, PhD / Director Xcelia. División de terapias Avanzadas del BST, Banc de Sang i Teixits
ClinicalTrials.gov Identifier:	NCT01227694 History of Changes
Other Study ID Numbers:	XCEL-M-09-01
Study First Received:	October 22, 2010
Last Updated:	July 22, 2011
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Banc de Sang i Teixits:

Cell therapy
Regenerative therapy
Advance therapy
Bone marrow
Mesenchymal stem cell

Autologous
Interventional clinical trial
Osteoarthrosis
Osteoarthritis
Knee

Additional relevant MeSH terms:

Cartilage Diseases
Joint Diseases
Knee Injuries
Osteoarthritis
Rheumatic Diseases
Osteoarthritis, Knee

Musculoskeletal Diseases
Connective Tissue Diseases
Leg Injuries
Wounds and Injuries
Arthritis

ClinicalTrials.gov processed this record on May 22, 2013