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

Condition

Hip and Knee Osteoarthritis

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

Condition Browse

Arm Group

Label: Hip Osteoarthritis

Label: Knee Osteoarthritis

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov