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Autologous Stem Cells in Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01485198
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Bone Marrow Autologous Stem Cells Infusion Drug: Acetaminophen Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.
Study Start Date : August 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Control
Patients treated with Acetaminophen
Drug: Acetaminophen
Acetaminophen (750mg orally TID) administration
Other Name: Knee treatment with NSAIDs

Experimental: Experimental
Patients who underwent a BMASC extraction and joint infusion
Procedure: Bone Marrow Autologous Stem Cells Infusion
Extraction and knee infusion of Bone Marrow Autologous Stem Cells
Other Name: Knee treatment with stem cells




Primary Outcome Measures :
  1. Define safety of BM extraction and stem cell joint infusion. [ Time Frame: 1 week ]

    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 :
  1. Efficacy of BMSC joint infusion at 4 weeks [ Time Frame: 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.


  2. Efficacy and final outcome of BMSC joint infusion at 6 months. [ Time Frame: 24 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 4 week, first week and baseline questionnaires.




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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485198


Locations
Mexico
Hematology Service
Monerrey, Nuevo Leon, Mexico, 64460
Traumatology Service
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Domingo Garay Mendoza, MD Hospital Universitario Dr. Jose E. Gonzalez
Study Director: Consuelo Mancias Guerra, MD Hospital Universitario Dr. Jose E. Gonzalez
Study Chair: Laura Villarreal Martínez, MD Hospital Universitario Dr. Jose E. Gonzalez

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Consuelo Mancias Guerra, Head of Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01485198     History of Changes
Other Study ID Numbers: HE11-022
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez:
osteoarthritis
knee
stem cell therapy
bone marrow
G-CSF

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics