Study Results
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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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2011-08-31
2014-05-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Patients treated with Acetaminophen
Acetaminophen
Acetaminophen (750mg orally TID) administration
Experimental
Patients who underwent a BMASC extraction and joint infusion
Bone Marrow Autologous Stem Cells Infusion
Extraction and knee infusion of Bone Marrow Autologous Stem Cells
Interventions
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Bone Marrow Autologous Stem Cells Infusion
Extraction and knee infusion of Bone Marrow Autologous Stem Cells
Acetaminophen
Acetaminophen (750mg orally TID) administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 30 years
Exclusion Criteria
* Active infection
* Recent joint infection
* Knee surgery history
* Knee joint fracture history
30 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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Consuelo Mancias Guerra
Head of Hematology Service
Principal Investigators
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Domingo Garay Mendoza, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Dr. Jose E. Gonzalez
Consuelo Mancias Guerra, MD
Role: STUDY_DIRECTOR
Hospital Universitario Dr. Jose E. Gonzalez
Laura Villarreal Martínez, MD
Role: STUDY_CHAIR
Hospital Universitario Dr. Jose E. Gonzalez
Locations
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Hematology Service
Monerrey, Nuevo León, Mexico
Traumatology Service
Monterrey, Nuevo León, Mexico
Countries
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References
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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.
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.
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.
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.
Related Links
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Traumatology Service Web Site
Other Identifiers
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HE11-022
Identifier Type: -
Identifier Source: org_study_id
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