Knee Osteoarthritis: FDA Approved Clinical Trial
The Orthohealing Center has been selected by Personalized Stem Cells, Inc. as one of the ten clinics in the United States to provide stem cell treatment in an FDA approved clinical trial. Our clinic was selected because of our extensive experience in regenerative medicine and dedication to advancement of FDA regulated treatments. Summary information is below. We would welcome the opportunity to speak with you regarding your interest in this clinical trial.
Clinical Trial: PSC-CP-001 – Stem Cell Treatment of Knee Osteoarthritis in One Knee
Clinical Trial Summary.
This clinical trial provides a stem cell product produced from a small lipoaspiration sample of your fat collected in our clinic. We ship the fat to the FDA-inspected Personalized Stem Cells laboratory in San Diego. The stem cells are extracted and manufactured into a cell product and tested for sterility and other quality tests. The cells are shipped back to our clinic for injection into your knee. All participants in the clinical trial will be receiving the investigational stem cell treatment.
Benefits from participation in PSC clinical trials include:
- Your cells are quality tested before use
- Processing meets FDA standards
- The clinical trial is approved by the FDA
- Your stem cells are stored for potential future use without another fat collection
- Treatment in the US
Possible Clinical Trial Benefits.
Published results from trials using a patient’s own stem cells from fat (related product type) have shown a number of benefits such as:
- Reduction of pain
- Improved range of motion
- Improved activity level
- Improved quality of life
- Reduction in use of pain medications
This is a clinical trial and you may not see any of the listed possible benefits.
Possible Risks and Discomforts from an Injection into your knee:
- Pain, swelling, redness, soreness or inflammation in, near or around the injected knee joint
- Infection in, near or around the injected knee joint
- Systemic infection resulting from infection in the knee
Although there is substantial literature regarding the long-term safety of this type of cellular therapy, Personalized Stem Cells, Inc. has not conducted any long-term safety trials of these stem cells from this specific process and there may be unforeseeable risks.
Clinical Trial Participant Activities (what is expected of you)
- Initial visit(s): physical examination, radiographs, history
- Blood and urine analyses (up to four times)
- Liposuction visit: have fat collected
- Telephone call with clinic – day after liposuction
- Knee injection visit: one knee will be injected with your stem cells
- Telephone call with clinic – day after knee injection
- Interim office visit – approximately 42 days (6 weeks) after knee injection
- Final office visit – approximately 84 days (12 weeks)
This is a Patient Funded trial. This means that the patient pays a fee at the beginning of the trial to cover all costs other than for Initial visit(s). There is no cost for the production of the investigational stem cell product.
Do I Qualify?
If you meet the following criteria:
- Age 18-80 years old
- Knee pain at least weekly for at least 3 months
- Failed minimum 6 weeks of conservative therapy
- Radiographic (x-ray) evidence of osteoarthritis
- Healthy other than osteoarthritis
- Active cancer
- Active infection
- Osteonecrosis, active immune disease, serious cardiac condition, epilepsy, uncontrolled diabetes
- Currently on prescribed immunosuppressive therapy
- History of treatment of alcohol or substance abuse
- Regular smoker
And if you don’t have any of the following:
Then you might be eligible to participant in this Patient Funded study