Mesenchymal Stromal Cells for Degenerative Meniscus Injury
Primary Purpose
Chronic Meniscal Injury
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
XCEL-M-ALPHA and standard rehabilitation
Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Meniscal Injury focused on measuring Chronic Meniscal Injury, Degenerative meniscus, Meniscus injury, Meniscal injury, Mesenchymal stromal cells, Mesenchymal stem cells, Advanced Therapy, Bone marrow
Eligibility Criteria
Inclusion Criteria:
- Patient between 40 and 60 years of age
- Degenerative meniscus injury grade 3 (Crues et al.)
- Indication of conservative treatment
- Normal alignment of the knee (between 3º varus and 10 º valgus)
- Patient is able to follow a rehabilitation program
- Informed consent given by the patient in writing
- Patient is able to understand the trial.
Exclusion Criteria:
- Traumatic meniscus injury
- Surgical intervention to the affected knee
- Local or systemic infection
- Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
- Significant abnormal laboratory tests that contraindicates participation in the trial.
- Pregnant women or intend to become pregnant or breast-feeding
- Neoplastic process within the previous 5 years or without complete remission.
- The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- Legally dependant patient.
- The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Sites / Locations
- ICATME-Hospital Quiron Dexeus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
XCEL-M-ALPHA and standard rehabilitation
standard rehabilitation
Arm Description
Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program
Standard rehabilitation program
Outcomes
Primary Outcome Measures
VAS for pain
Visual analogue scale (VAS) for pain at 12 month follow-up.
Secondary Outcome Measures
Safety
Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs.
Efficacy by MRI
Efficacy will be assessed by qualitative and quantitative changes of the meniscus and articular cartilage by imaging procedures (MRI) at 6 and 12 month follow-up.
VAS for pain
Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up.
Efficacy by clinical questionnaires
IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up
Full Information
NCT ID
NCT02033525
First Posted
January 8, 2014
Last Updated
January 8, 2018
Sponsor
Banc de Sang i Teixits
Collaborators
Hospital Universitari Quirón Dexeus, Ministerio de Sanidad, Servicios Sociales e Igualdad
1. Study Identification
Unique Protocol Identification Number
NCT02033525
Brief Title
Mesenchymal Stromal Cells for Degenerative Meniscus Injury
Official Title
A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 31, 2014 (Actual)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
May 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
Hospital Universitari Quirón Dexeus, Ministerio de Sanidad, Servicios Sociales e Igualdad
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.
Detailed Description
This is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (Crues et al.) will enter the study with the primary objective of assessing the efficacy of the treatment by VAS of pain at 12 month. Secondary objectives are to evaluate the safety and efficacy through imaging procedures and clinical questionnaires (IKDC, KOOS, Lysholm and SF-36.
Patients will be randomized to one of the two treatment arms (XCEL-M-ALPHA and standard rehabilitation program or standard rehabilitation program alone). Thereafter, patients will be followed for 12 months.
Imaging assessment will be performed by an independent blinded radiologist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Meniscal Injury
Keywords
Chronic Meniscal Injury, Degenerative meniscus, Meniscus injury, Meniscal injury, Mesenchymal stromal cells, Mesenchymal stem cells, Advanced Therapy, Bone marrow
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XCEL-M-ALPHA and standard rehabilitation
Arm Type
Experimental
Arm Description
Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program
Arm Title
standard rehabilitation
Arm Type
Active Comparator
Arm Description
Standard rehabilitation program
Intervention Type
Drug
Intervention Name(s)
XCEL-M-ALPHA and standard rehabilitation
Other Intervention Name(s)
XCEL-M-ALPHA
Intervention Description
Intraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank)
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Standard rehabilitation program
Primary Outcome Measure Information:
Title
VAS for pain
Description
Visual analogue scale (VAS) for pain at 12 month follow-up.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Safety
Description
Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs.
Time Frame
12 month
Title
Efficacy by MRI
Description
Efficacy will be assessed by qualitative and quantitative changes of the meniscus and articular cartilage by imaging procedures (MRI) at 6 and 12 month follow-up.
Time Frame
6 and 12 month
Title
VAS for pain
Description
Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up.
Time Frame
1, 3 and 6 month
Title
Efficacy by clinical questionnaires
Description
IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up
Time Frame
3, 6 and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient between 40 and 60 years of age
Degenerative meniscus injury grade 3 (Crues et al.)
Indication of conservative treatment
Normal alignment of the knee (between 3º varus and 10 º valgus)
Patient is able to follow a rehabilitation program
Informed consent given by the patient in writing
Patient is able to understand the trial.
Exclusion Criteria:
Traumatic meniscus injury
Surgical intervention to the affected knee
Local or systemic infection
Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
Significant abnormal laboratory tests that contraindicates participation in the trial.
Pregnant women or intend to become pregnant or breast-feeding
Neoplastic process within the previous 5 years or without complete remission.
The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Legally dependant patient.
The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Carles Monllau, MD, PhD
Organizational Affiliation
ICATME-Hospital Quiron Dexeus
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICATME-Hospital Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.bancsang.net/en/index.html
Description
Blood and tissue bank of Catalonia
URL
http://www.icatme.com/
Description
Fundación ICATME (Spanish only)
Learn more about this trial
Mesenchymal Stromal Cells for Degenerative Meniscus Injury
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