- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01601951
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
Autologous Bone Marrow Concentrate Database Outcomes Research Project
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
-
Des Plaines, Illinois, United States, 60016
- Regenerative Pain Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hip Osteoarthritis
|
This is strictly data collection and outcomes based.
The procedure is not part of this study
|
Knee Osteoarthritis
|
This is strictly data collection and outcomes based.
The procedure is not part of this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Pain Scale
Time Frame: Baseline, 6 weeks, 3 months, 1 year
|
Change in subjective pain measure
|
Baseline, 6 weeks, 3 months, 1 year
|
Harris Hip Score or Knee Society Score
Time Frame: Baeline, 6 weeks, 3 months, 1 year
|
Change in subjective pain, function, functional activity measurement and a clinical physical exam
|
Baeline, 6 weeks, 3 months, 1 year
|
Physician Global Assessment
Time Frame: Baseline, 6 weeks, 3 months, 1 year
|
Change in physician rated disease activity measurement
|
Baseline, 6 weeks, 3 months, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiologic
Time Frame: Baseline, 1 year
|
Radiographic changes of the hip or knee
|
Baseline, 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MM-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip and Knee Osteoarthritis
-
Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of AlbertaActive, not recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis, Knee | Osteo Arthritis Knee | Osteoarthritis, Hip | Hip OsteoarthritisCanada
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
CrystalGenomics, Inc.CompletedLocalized Primary Osteoarthritis of Hip | Localized Primary Osteoarthritis of KneeKorea, Republic of
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
West Virginia UniversityAgency for Healthcare Research and Quality (AHRQ)WithdrawnKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Procedural, Bone Marrow concentrate injection
-
Bone and Joint Clinic of Baton RougeActive, not recruitingDegenerative Disc Disease | Spine DegenerationUnited States
-
Franziskus-KrankenhausKlinikum Karlsbad-Langensteinbach; Krankenhaus der Barmherzigen Brüder Trier; Stiftungsklinikum BoppardUnknownIschemia | Diabetic Foot | Leg Ulcer | Peripheral Arterial Occlusive Disease | Peripheral Vascular Disease | GangreneGermany
-
Istituto Ortopedico RizzoliRecruitingBone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee OsteoarthritisKnee OsteoarthritisItaly
-
Stanford UniversityWithdrawnRotator Cuff Tear | Osteoarthritis, Knee | Cartilage Degeneration
-
Istituto Ortopedico RizzoliCompleted
-
Rush University Medical CenterRecruitingOsteoarthritis of the KneeUnited States
-
APM Spine and Sports PhysiciansUnknownDiscogenic PainUnited States
-
Cardiogenesis Corporation, a wholly-owned subsidiary...TerminatedAnginaSpain, Russian Federation
-
Hospital ZnojmoCompleted
-
Hospital for Special Surgery, New YorkEmory University; Arthritis FoundationNot yet recruitingAnterior Cruciate Ligament Injuries | Bone Marrow Aspirate Concentrate | ACL Injury | Post-Traumatic Osteoarthritis of KneeUnited States