Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Stem Cells in Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 26, 2011
First Posted Date  ICMJE December 5, 2011
Last Update Posted Date March 1, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01485198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2011)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Stem Cells in Osteoarthritis
Official Title  ICMJE Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Procedure: Bone Marrow Autologous Stem Cells Infusion
    Extraction and knee infusion of Bone Marrow Autologous Stem Cells
    Other Name: Knee treatment with stem cells
  • Drug: Acetaminophen
    Acetaminophen (750mg orally TID) administration
    Other Name: Knee treatment with NSAIDs
Study Arms  ICMJE
  • Active Comparator: Control
    Patients treated with Acetaminophen
    Intervention: Drug: Acetaminophen
  • Experimental: Experimental
    Patients who underwent a BMASC extraction and joint infusion
    Intervention: Procedure: Bone Marrow Autologous Stem Cells Infusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2016)
61
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2011)
30
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01485198
Other Study ID Numbers  ICMJE HE11-022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor  ICMJE Hospital Universitario Dr. Jose E. Gonzalez
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital Universitario Dr. Jose E. Gonzalez
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP