We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee 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: NCT01601951
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Regenerative Pain Center, Illinois

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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

Condition or disease Intervention/treatment
Hip and Knee Osteoarthritis Other: Procedural, Bone Marrow concentrate injection

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autologous Bone Marrow Concentrate Database Outcomes Research Project
Study Start Date : April 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Visual Analog Pain Scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
    Change in subjective pain measure

  2. 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

  3. Physician Global Assessment [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
    Change in physician rated disease activity measurement


Secondary Outcome Measures :
  1. Radiologic [ Time Frame: Baseline, 1 year ]
    Radiographic changes of the hip or knee


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01601951


Locations
Layout table for location information
United States, Illinois
Regenerative Pain Center
Des Plaines, Illinois, United States, 60016
Sponsors and Collaborators
Regenerative Pain Center, Illinois
Investigators
Layout table for investigator information
Principal Investigator: Mitchell Sheinkop, M.D. Regenerative Pain Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Regenerative Pain Center, Illinois
ClinicalTrials.gov Identifier: NCT01601951    
Other Study ID Numbers: MM-01
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by Regenerative Pain Center, Illinois:
Osteoarthritis
Stem Cell Injections
Bone Marrow
Autologous
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases