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

NCT ID: NCT01601951

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Hip and Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hip Osteoarthritis

Procedural, Bone Marrow concentrate injection

Intervention Type OTHER

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

Knee Osteoarthritis

Procedural, Bone Marrow concentrate injection

Intervention Type OTHER

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

Interventions

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Procedural, Bone Marrow concentrate injection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regenerative Pain Center, Illinois

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Sheinkop, M.D.

Role: PRINCIPAL_INVESTIGATOR

Regenerative Pain Center

Locations

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Regenerative Pain Center

Des Plaines, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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MM-01

Identifier Type: -

Identifier Source: org_study_id

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