Study Details

PSC-CP-001 – Stem Cell Treatment of Knee Osteoarthritis in One Knee Study Summary:

This clinical trial provides a stem cell product created from a small lipoaspiration sample of your fat. The fat is collected by the physician and shipped to our central FDA-inspected laboratory in San Diego. The stem cells are extracted and manufactured into a cell product and tested for sterility and other quality tests. Then the cells are shipped back to the clinic for injection into your knee.

Benefits from participation in PSC clinical trials include:

• Your cells are quality tested before use
• Processing meets FDA standards
• Clinical trials are approved by the FDA
• Storage of stem cells for potential future use without another fat collection
• Treatments offered 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 Liposuction (fat collection):

• Pain, swelling, redness, soreness or infection at the site of liposuction collection
• Skin contour irregularities due to uneven fat removal
• Fluid accumulation under the skin
• Temporary decrease in skin sensation at collection site
• Reaction to anesthetic

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

Unforeseeable risks

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.

Study Participant Activities

• 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)

Costs

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 standard diagnostic evaluation and for the drug (your own stem cells). The trial total cost is $8,900 and includes the banking of your extra stem cells for one year.

Do I Qualify

Trial participants must be between 18 and 80 years old and in generally good health. A physical examination, X-Rays, evaluation of blood work, and health history will determine eligibility.

If you meet the following criteria:

• 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

And if you don’t have any of the following:

• 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

Then you might be eligible to participant in this Patient Funded study.

Link to Personalized Stem Cells Website