Trials / Terminated
TerminatedNCT02370823
A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Regenexx, LLC · Industry
- Sex
- All
- Age
- 35 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment.
Detailed description
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx SD treatment (day 0). Secondary objective is an evaluation of possible direct and/or indirect associations between the measured levels of proteins and/or cellular components of the synovial fluid in the osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary objective will include MRI evidence of cartilage repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Regenexx SD | stem cell treatment |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2015-02-25
- Last updated
- 2018-03-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02370823. Inclusion in this directory is not an endorsement.