Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis

March 14, 2014 updated by: Regenerative Pain Center, Illinois

Autologous Bone Marrow Concentrate Database Outcomes Research Project

The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.

Inclusion Criteria:

  • Subjects must be scheduled for an autologous bone marrow hip or knee injection
  • Subjects must have a diagnosis of hip or knee osteoarthritis
  • Subjects must be between the ages of 18 and 85
  • Subjects must be willing and able to sign Informed Consent
  • Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

  • Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
  • Subjects for whom baseline data is not available

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

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

  • United States
    • Illinois
      • Des Plaines, Illinois, United States, 60016
        • Regenerative Pain Center

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection

Description

Inclusion Criteria:

  • Subjects must be scheduled for an autologous bone marrow hip or knee injection
  • Subjects must have a diagnosis of hip or knee osteoarthritis
  • Subjects must be between the ages of 18 and 85
  • Subjects must be willing and able to sign Informed Consent
  • Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

  • Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
  • Subjects for whom baseline data is not available

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hip Osteoarthritis
Other: Procedural, Bone Marrow concentrate injection
This is strictly data collection and outcomes based. The procedure is not part of this study
Knee Osteoarthritis
Other: Procedural, Bone Marrow concentrate injection
This is strictly data collection and outcomes based. The procedure is not part of this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Pain Scale
Time Frame: Baseline, 6 weeks, 3 months, 1 year
Change in subjective pain measure
Baseline, 6 weeks, 3 months, 1 year
Harris Hip Score or Knee Society Score
Time Frame: Baeline, 6 weeks, 3 months, 1 year
Change in subjective pain, function, functional activity measurement and a clinical physical exam
Baeline, 6 weeks, 3 months, 1 year
Physician Global Assessment
Time Frame: Baseline, 6 weeks, 3 months, 1 year
Change in physician rated disease activity measurement
Baseline, 6 weeks, 3 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiologic
Time Frame: Baseline, 1 year
Radiographic changes of the hip or knee
Baseline, 1 year

Collaborators and Investigators

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

Sponsor

Regenerative Pain Center, Illinois

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

April 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-01

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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