Autologous Stem Cells in Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Bone Marrow Autologous Stem Cells Infusion
Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, knee, stem cell therapy, bone marrow, G-CSF
Eligibility Criteria
Inclusion Criteria:
- Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale
- Age > 30 years
Exclusion Criteria:
- Neurodegenerative, autoimmune, genetic or psychiatric diseases
- Active infection
- Recent joint infection
- Knee surgery history
- Knee joint fracture history
Sites / Locations
- Hematology Service
- Traumatology Service
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Experimental
Arm Description
Patients treated with Acetaminophen
Patients who underwent a BMASC extraction and joint infusion
Outcomes
Primary Outcome Measures
Define safety of BM extraction and stem cell joint infusion.
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.
Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes at first week to the baseline questionnaire.
Secondary Outcome Measures
Efficacy of BMSC joint infusion at 4 weeks
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.
Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with first week and baseline questionnaires.
Efficacy and final outcome of BMSC joint infusion at 6 months.
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.
Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with 4 week, first week and baseline questionnaires.
Full Information
NCT ID
NCT01485198
First Posted
November 26, 2011
Last Updated
February 29, 2016
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
1. Study Identification
Unique Protocol Identification Number
NCT01485198
Brief Title
Autologous Stem Cells in Osteoarthritis
Official Title
Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will be allocated into two groups:
The control group will receive Acetaminophen 750mg orally every 8 hours
The experimental group will receive Autologous Hematopoietic Stem Cells from bone marrow (BMASC)
Signed informed consent is required, as well as answering a questionnaire.
Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3 consecutive days and, on the 4th day a bone marrow harvest under general sedation will be performed from posterior iliac crests. The patient will remain in the recovery room while the cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to the joint under local anesthesia.
The procedure is ambulatory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, knee, stem cell therapy, bone marrow, G-CSF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients treated with Acetaminophen
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients who underwent a BMASC extraction and joint infusion
Intervention Type
Procedure
Intervention Name(s)
Bone Marrow Autologous Stem Cells Infusion
Other Intervention Name(s)
Knee treatment with stem cells
Intervention Description
Extraction and knee infusion of Bone Marrow Autologous Stem Cells
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Knee treatment with NSAIDs
Intervention Description
Acetaminophen (750mg orally TID) administration
Primary Outcome Measure Information:
Title
Define safety of BM extraction and stem cell joint infusion.
Description
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.
Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes at first week to the baseline questionnaire.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Efficacy of BMSC joint infusion at 4 weeks
Description
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.
Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with first week and baseline questionnaires.
Time Frame
4 weeks
Title
Efficacy and final outcome of BMSC joint infusion at 6 months.
Description
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.
Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with 4 week, first week and baseline questionnaires.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale
Age > 30 years
Exclusion Criteria:
Neurodegenerative, autoimmune, genetic or psychiatric diseases
Active infection
Recent joint infection
Knee surgery history
Knee joint fracture history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domingo Garay Mendoza, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Consuelo Mancias Guerra, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laura Villarreal Martínez, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Chair
Facility Information:
Facility Name
Hematology Service
City
Monerrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Traumatology Service
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
21518322
Citation
Davatchi F, Abdollahi BS, Mohyeddin M, Shahram F, Nikbin B. Mesenchymal stem cell therapy for knee osteoarthritis. Preliminary report of four patients. Int J Rheum Dis. 2011 May;14(2):211-5. doi: 10.1111/j.1756-185X.2011.01599.x. Epub 2011 Mar 4.
Results Reference
result
PubMed Identifier
20934693
Citation
de Girolamo L, Bertolini G, Cervellin M, Sozzi G, Volpi P. Treatment of chondral defects of the knee with one step matrix-assisted technique enhanced by autologous concentrated bone marrow: in vitro characterisation of mesenchymal stem cells from iliac crest and subchondral bone. Injury. 2010 Nov;41(11):1172-7. doi: 10.1016/j.injury.2010.09.027. Epub 2010 Oct 8.
Results Reference
result
PubMed Identifier
21300401
Citation
Chen FM, Wu LA, Zhang M, Zhang R, Sun HH. Homing of endogenous stem/progenitor cells for in situ tissue regeneration: Promises, strategies, and translational perspectives. Biomaterials. 2011 Apr;32(12):3189-209. doi: 10.1016/j.biomaterials.2010.12.032.
Results Reference
result
PubMed Identifier
28752679
Citation
Garay-Mendoza D, Villarreal-Martinez L, Garza-Bedolla A, Perez-Garza DM, Acosta-Olivo C, Vilchez-Cavazos F, Diaz-Hutchinson C, Gomez-Almaguer D, Jaime-Perez JC, Mancias-Guerra C. The effect of intra-articular injection of autologous bone marrow stem cells on pain and knee function in patients with osteoarthritis. Int J Rheum Dis. 2018 Jan;21(1):140-147. doi: 10.1111/1756-185X.13139. Epub 2017 Jul 27.
Results Reference
derived
Links:
URL
http://www.ortopedia.org/
Description
Traumatology Service Web Site
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Autologous Stem Cells in Osteoarthritis
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