Clinical trial NCT01227694: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Banc de Sang i Teixits
Sponsor class: OTHER
Collaborators: name: Centro Medico Teknon
name: Institut de Terapia Regenerativa Tissular
name: Cetir Sant Jordi, S.a..
First posted: 2010-10-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
timeFrame: 12 months
measure: Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy by imaging procedures.
timeFrame: 6 months
measure: Efficacy by imaging procedures.
timeFrame: 12 month
measure: Clinical outcomes.
timeFrame: 3 month
measure: Clinical outcomes.
timeFrame: 6 months
measure: Clinical outcomes.
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Medico Teknon-ITRT
Study officials:
affiliation: Institut de Teràpia Regenerativa Tissular (ITRT)
name: Robert Soler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.