Hip and Knee OsteoarthritisNCT01601951
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
An observational study of Hip and Knee Osteoarthritis, run by Regenerative Pain Center, Illinois at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip and Knee Osteoarthritis
- What is being tested?
- Procedural, Bone Marrow concentrate injection
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Regenerative Pain Center
Des Plaines, Illinois, 60016
About this study
Official title: 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:
Read more
- 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
- Being tested
- Procedural, Bone Marrow concentrate injection
- Keywords
- Osteoarthritis, Stem Cell Injections, Bone Marrow, Autologous
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedural, Bone Marrow concentrate injectionOther
This is strictly data collection and outcomes based. The procedure is not part of this study
| Study group | Role | What they receive |
|---|---|---|
| Hip Osteoarthritis | Not described Receives: Other: Procedural, Bone Marrow concentrate injection | |
| Knee Osteoarthritis | Not described Receives: Other: Procedural, Bone Marrow concentrate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
Change in subjective pain measure
Measured: 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
Measured: Baeline, 6 weeks, 3 months, 1 year
Physician Global Assessment
Change in physician rated disease activity measurement
Measured: Baseline, 6 weeks, 3 months, 1 year
Secondary outcomes (1)
Radiologic
Radiographic changes of the hip or knee
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip and Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenerative Pain Center, Illinois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Sheinkop, M.D., Principal investigator, Regenerative Pain Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601951
- Sponsor's protocol ID
- MM-01
- Status last verified
- Mar 2014
- First submitted
- 14 May 2012
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Concentrate Database Outcomes Research Project
- ClinicalTrials.gov ID
- NCT01601951
- Acronym / sponsor ID
- MM-01
- Conditions
- Hip and Knee Osteoarthritis
- Keywords
- Osteoarthritis, Stem Cell Injections, Bone Marrow, Autologous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Regenerative Pain Center, IllinoisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Osteoarthritis | – | Other: Procedural, Bone Marrow concentrate injection |
| Knee Osteoarthritis | – | Other: Procedural, Bone Marrow concentrate injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedural, Bone Marrow concentrate injectionThis is strictly data collection and outcomes based. The procedure is not part of this study | Other | Hip Osteoarthritis, Knee Osteoarthritis |
Primary outcome
Visual Analog Pain Scale
Time frame: Baseline, 6 weeks, 3 months, 1 year
Change in subjective pain measure
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
Physician Global Assessment
Time frame: Baseline, 6 weeks, 3 months, 1 year
Change in physician rated disease activity measurement
1 secondary outcome
Radiologic
Time frame: Baseline, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Sheinkop, M.D. principal investigator
Regenerative Pain Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip and Knee Osteoarthritis, run by Regenerative Pain Center, Illinois at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Scale (time frame: Baseline, 6 weeks, 3 months, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.