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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regenerative Pain Center, Illinois
ClinicalTrials.gov Identifier:
NCT01601951
First received: May 14, 2012
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention
Hip and Knee Osteoarthritis
Other: Procedural, Bone Marrow concentrate injection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autologous Bone Marrow Concentrate Database Outcomes Research Project

Resource links provided by NLM:


Further study details as provided by Regenerative Pain Center, Illinois:

Primary Outcome Measures:
  • Visual Analog Pain Scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
    Change in subjective pain measure

  • Harris Hip Score or Knee Society Score [ Time Frame: Baeline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
    Change in subjective pain, function, functional activity measurement and a clinical physical exam

  • Physician Global Assessment [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
    Change in physician rated disease activity measurement


Secondary Outcome Measures:
  • Radiologic [ Time Frame: Baseline, 1 year ] [ Designated as safety issue: No ]
    Radiographic changes of the hip or knee


Enrollment: 12
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Regenerative Pain Center, Illinois
ClinicalTrials.gov Identifier: NCT01601951     History of Changes
Other Study ID Numbers: MM-01
Study First Received: May 14, 2012
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014