Frequently Asked Questions
The cells produced from the processing of adipose (fat) are commonly referred to as Stromal Vascular Fraction (SVF) cells. Our clinical trials are designed to evaluate these characteristics of these cells. The SVF contains growth factors and multiple cell types, including mesenchymal stem cells, which have been shown in published clinical trials to be useful in:
- Reduction of pain
- Improved range of motion
- Improved activity level
- Improved quality of life
- Reduction in use of pain medications
PSC supplies stem cells only to physicians treating certain conditions under FDA approved clinical trials. Currently arthritis is being treated. Please see the Clinical Trials page for more information.
- After a health evaluation and determination of eligibility for the trial, the PSC network physician will collect your fat during a small liposuction procedure.
- The fat collected will be shipped overnight to Personalized Stem Cells for processing.
- Cells will be frozen using a special method as part of the FDA approved clinical trial.
- Cells will be tested to ensure quality.
- Frozen vial(s) will be shipped to your physician according to your treatment schedule, approximately three weeks after the collection.
PSC plans to apply for FDA approval for multiple clinical trials to treat additional medical conditions as indicated by the latest clinical evidence and science. Please see the Clinical Trials page for more information. Please contact us with your specific interest so that we can provide updates as available.
Yes. The PSC cell banking service is designed for long-term stem cell storage if there are extra cells. A Cell Banking Agreement will be provided to each patient.
The founders of PSC have more than 20 years of experience conducting clinical trials and operating service laboratories under FDA and USDA guidelines. Each patient’s cells will be tested for sterility, endotoxin, cell count and identity, and cell viability.
Your physician will review with you the possible risks that are in the Consent Form which is reviewed and approved by the Institutional Review Board (IRB) for each clinical trial. Clinical trials with related products using stem cells derived from adipose tissue indicate that adipose derived stem cells have a very good safety profile.
Cultured stem cells are stem cells that are grown from your originally donated stem cells to provide more stem cells for treatment without need for additional fat collection. PSC may culture (grow additional) cells for potential use in future FDA approved clinical trials.
The cells are packaged in sterile vials and shipped in a cryogenic shipper. The cells are thawed at room temperature and ready to inject with no further processing.
The cost for participation in each clinical trial will vary depending on the cost for diagnosis, eligibility screening, number and type of treatments, and follow up exams. You should review costs with your physician prior to signing the Informed Consent form.
Stem cell clinical trials are not typically covered by insurance. The cost of diagnosis and post-treatment visits or therapy may be covered. You should review coverages with your insurance carrier prior to enrollment in the clinical trial.
- Fat contains 100 to 500 times more mesenchymal stem cells than bone marrow
- Fat is plentiful and easy to harvest
- Bone marrow harvest requires drilling into your bone
- Bone marrow may contain bone fragments, which is not ideal for injecting into joints, tendons, or ligaments
- Bone marrow gets depleted of stem cells as you age and fat retains its stem cells longer
Each clinical study will have an age limit. Our current study limit is 80 years of age. Enrollment also includes evaluation of each individual for risk versus benefit. Future studies may increase the age limit.
Your doctor will review your current medications as part of the eligibility screening process for the clinical trial.