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

NCT01601951 | Completed

• 1 other identifier: MM-01
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Hip and Knee Osteoarthritis

Keywords

Osteoarthritis; Stem Cell Injections; Bone Marrow; Autologous

Outcome Measures

Primary Outcomes (3)

• Visual Analog Pain Scale

  Change in subjective pain measure

  Baseline, 6 weeks, 3 months, 1 year

• 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

• Physician Global Assessment

  Change in physician rated disease activity measurement

  Baseline, 6 weeks, 3 months, 1 year

Secondary Outcomes (1)

• Radiologic

  Baseline, 1 year

Study Arms (2)

Hip Osteoarthritis

Other: Procedural, Bone Marrow concentrate injection

Knee Osteoarthritis

Other: Procedural, Bone Marrow concentrate injection

Interventions

Procedural, Bone Marrow concentrate injection OTHER

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

Hip Osteoarthritis; Knee Osteoarthritis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenerative Pain Center, Illinois: lead

Study Sites (1)

Regenerative Pain Center

Des Plaines, Illinois, 60016, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mitchell Sheinkop, M.D.

  Regenerative Pain Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 18, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

US (1)