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

Hip and Knee Osteoarthritis Clinical Trial

Official title:

Autologous Bone Marrow Concentrate Database Outcomes Research Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601951
• Other study ID #: MM-01
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: March 14, 2014
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Regenerative Pain Center, Illinois
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hip and Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Procedural, Bone Marrow concentrate injection
This is strictly data collection and outcomes based. The procedure is not part of this study

Locations

Country	Name	City	State
United States	Regenerative Pain Center	Des Plaines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Regenerative Pain Center, Illinois

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Scale	Change in subjective pain measure	Baseline, 6 weeks, 3 months, 1 year	No
Primary	Harris Hip Score or Knee Society Score	Change in subjective pain, function, functional activity measurement and a clinical physical exam	Baeline, 6 weeks, 3 months, 1 year	No
Primary	Physician Global Assessment	Change in physician rated disease activity measurement	Baseline, 6 weeks, 3 months, 1 year	No
Secondary	Radiologic	Radiographic changes of the hip or knee	Baseline, 1 year	No