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Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

NCT ID: NCT01227694

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee Knee Injuries Joint Diseases Rheumatic Diseases Cartilage Diseases

Keywords

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Cell therapy Regenerative therapy Advance therapy Bone marrow Mesenchymal stem cell Autologous Interventional clinical trial Osteoarthrosis Osteoarthritis Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Autologous MSC knee implantation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Xcel-m-condro-alpha

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Medico Teknon

OTHER

Sponsor Role collaborator

Institut de Terapia Regenerativa Tissular

OTHER

Sponsor Role collaborator

Cetir Sant Jordi, S.a..

INDIV

Sponsor Role collaborator

Banc de Sang i Teixits

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Soler, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Teràpia Regenerativa Tissular (ITRT)

Locations

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Centro Medico Teknon-ITRT

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 25769789 (View on PubMed)

Related Links

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http://www.itrt.es

Institut de Terapia Regenerativa Tissular (ITRT), Barcelona, Spain

http://www.bancsang.net

Banc de Sang i Teixits

Other Identifiers

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XCEL-M-09-01

Identifier Type: -

Identifier Source: org_study_id