Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227694
• Other study ID #: XCEL-M-09-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 22, 2010
• Last updated: December 10, 2015
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: November 2015
• Source: Banc de Sang i Teixits
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Centro Medico Teknon-ITRT	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Banc de Sang i Teixits	Centro Medico Teknon, Cetir Sant Jordi, S.a.., Institut de Terapia Regenerativa Tissular

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Efficacy by imaging procedures.	Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).	6 months	No
Secondary	Efficacy by imaging procedures.	Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).	12 month	No
Secondary	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).	3 month	Yes
Secondary	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).	6 months	Yes
Secondary	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).	12 months	Yes

External Links

•   Banc de Sang i Teixits
•   Institut de Terapia Regenerativa Tissular (ITRT), Barcelona, Spain