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

This study is currently recruiting participants.

Verified May 2012 by Regenerative Pain Center, Illinois 

First Received on May 14, 2012.   Last Updated on May 16, 2012   History of Changes

Sponsor:

Regenerative Pain Center, Illinois

Information provided by (Responsible Party):

Regenerative Pain Center, Illinois

ClinicalTrials.gov Identifier:

NCT01601951

Purpose

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

Condition

Intervention

Hip and Knee Osteoarthritis Other: Procedural, Bone Marrow concentrate injection

 

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autologous Bone Marrow Concentrate Database Outcomes Research Project

Resource links provided by NLM: 

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources 

Further study details as provided by Regenerative Pain Center, Illinois:

Primary Outcome Measures:

  • Visual Analog Pain Scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]

Change in subjective pain measure

  • Harris Hip Score or Knee Society Score [ Time Frame: Baeline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]

Change in subjective pain, function, functional activity measurement and a clinical physical exam

  • Physician Global Assessment [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]

Change in physician rated disease activity measurement

Secondary Outcome Measures:

  • Radiologic [ Time Frame: Baseline, 1 year ] [ Designated as safety issue: No ]

Radiographic changes of the hip or knee

Estimated Enrollment: 15
Study Start Date: April 2012

 

Groups/Cohorts

Assigned Interventions

Hip Osteoarthritis Other: Procedural, Bone Marrow concentrate injection

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

Knee Osteoarthritis Other: Procedural, Bone Marrow concentrate injection

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

Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601951

Contacts

Contact: Mary Langhenry, PT 312-475-1896 mlanghenry@yahoo.com
Contact: Jennifer Kelly 312-475-2958 jkelly@weil4feet.com

Locations

United States, Illinois
Regenerative Pain Center Recruiting
Des Plaines, Illinois, United States, 60016
Principal Investigator: Mitchell Sheinkop, M.D.            

Sponsors and Collaborators

Regenerative Pain Center, Illinois

Investigators

Principal Investigator: Mitchell Sheinkop, M.D. Regenerative Pain Center

 More Information
No publications provided

Responsible Party: Regenerative Pain Center, Illinois
ClinicalTrials.gov Identifier: NCT01601951     History of Changes
Other Study ID Numbers: MM-01
Study First Received: May 14, 2012
Last Updated: May 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Regenerative Pain Center, Illinois:

Osteoarthritis
Stem Cell Injections
Bone Marrow
Autologous

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 20, 2012

Mitchell B. Sheinkop, M.D.

847-390-7666 or 847-390-7666
1565 N. LaSalle Street .  Chicago . Illinois . 60610

 

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