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

Autologous Bone Marrow Concentrate Database Outcomes Research Project

Sponsors

Lead Sponsor: Regenerative Pain Center, Illinois

Source 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

Overall Status Completed
Start Date April 2012
Completion Date March 2014
Primary Completion Date March 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Visual Analog Pain Scale Baseline, 6 weeks, 3 months, 1 year
Harris Hip Score or Knee Society Score Baeline, 6 weeks, 3 months, 1 year
Physician Global Assessment Baseline, 6 weeks, 3 months, 1 year
Secondary Outcome
Measure Time Frame
Radiologic Baseline, 1 year
Enrollment 12
Condition
Intervention

Intervention Type: Other

Intervention Name: Procedural, Bone Marrow concentrate injection

Description: This is strictly data collection and outcomes based. The procedure is not part of this study

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mitchell Sheinkop, M.D. Principal Investigator Regenerative Pain Center
Location
Facility: Regenerative Pain Center
Location Countries

United States

Verification Date

March 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Hip Osteoarthritis

Label: Knee Osteoarthritis

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov