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

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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

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 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
U.S. FDA Resources

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



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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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

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
United States, Illinois
Regenerative Pain Center
Des Plaines, Illinois, United States, 60016
Sponsors and Collaborators
Regenerative Pain Center, Illinois
Investigators
Principal Investigator: Mitchell Sheinkop, M.D. Regenerative Pain Center

Responsible Party: Regenerative Pain Center, Illinois
ClinicalTrials.gov Identifier: NCT01601951     History of Changes
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:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases