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CompletedNCT01601951Updated Mar 18, 2014

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

An observational study in Hip and Knee Osteoarthritis, sponsored by Regenerative Pain Center, Illinois. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-03-18.

Sponsored by Regenerative Pain Center, Illinois · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 85 Years
Sex
All
01

Study 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
02

Conditions studied

  • Hip and Knee Osteoarthritis

Keywords

  • Osteoarthritis
  • Stem Cell Injections
  • Bone Marrow
  • Autologous
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Regenerative Pain Center, Illinois as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)

Groups and cohorts

  • Hip Osteoarthritis

    Other: Procedural, Bone Marrow concentrate injection

  • Knee Osteoarthritis

    Other: Procedural, Bone Marrow concentrate injection

Interventions

  • OtherProcedural, Bone Marrow concentrate injection

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

06

What researchers measure

Primary outcomes

  1. Visual Analog Pain Scale

    Change in subjective pain measure

    Time frame: Baseline, 6 weeks, 3 months, 1 year

  2. Harris Hip Score or Knee Society Score

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

    Time frame: Baeline, 6 weeks, 3 months, 1 year

  3. Physician Global Assessment

    Change in physician rated disease activity measurement

    Time frame: Baseline, 6 weeks, 3 months, 1 year

Secondary outcomes

  1. Radiologic

    Radiographic changes of the hip or knee

    Time frame: Baseline, 1 year

07

Study locations

1 site
  • Regenerative Pain Center
    Des Plaines, Illinois 60016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01601951
Lead sponsor
Regenerative Pain Center, Illinois
Responsible party
Sponsor
First posted
May 18, 2012
Start date
Apr 2012
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Mar 18, 2014

Study contacts

Mitchell Sheinkop, M.D.
principal investigator · Regenerative Pain Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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