Autologous Stem Cells in Osteoarthritis

February 29, 2016 updated by: Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monerrey, Nuevo Leon, Mexico, 64460
        • Hematology Service
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Traumatology Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Patients treated with Acetaminophen
Drug: Acetaminophen
Acetaminophen (750mg orally TID) administration
Other Names:
  • 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 Names:
  • Knee treatment with stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 26, 2011

First Submitted That Met QC Criteria

December 2, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE11-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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