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Frequently Asked Questions

Why are Stem Cell Recruitment Therapy® products a better solution for patients suffering from joint, soft tissue and spine pain?

Stem Cell Recruitment Therapy® utilizes acellular structural placental-based tissue allograft (TA) products. A TA contains a naturally occurring extra cellular matrix (ECM) comprised of fibrous proteins that provide structural support for tissue regeneration. ECMs contain highly regenerative growth factors to assist in modulating inflammation, tissue formation and tissue remodeling. Furthermore, TAs are produced from health human donors, intended for homologous use to supplement or replace damaged or inadequate connective tissue.

Where do structural placental-based tissue allografts come from?

Tissue Allografts are produced from health human donors, intended for homologous use to supplement or replace damaged or inadequate connective tissue. TAs are obtained from elective, full-term live cesarean section delivery. All donors provide consent and are screened per FDA/AATB guidelines.

What is the difference between cord blood and tissue allografts?

Tissue allografts are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public Health Service (PHS) Act. However, cord blood is classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 351 of the Public Health Service (PHS) Act. According to the National Cord Blood Program, cord blood contains all the normal elements of blood – red blood cells, white blood cells, platelets and plasma. But it is also rich in hematopoietic (blood-forming) stem cells, similar to those found in bone marrow. On the other hand, Stem Cell Recruitment® products utilize acellular placental-derived tissue allografts that are not blood and do not contain live, viable cells or the normal elements of blood like red blood cells, white blood cells, platelets and plasma. Tissue allografts are comprised of extracellular matrix (ECM) derived from non-amnion placental tissue. It is intended to serve as a scaffold that provides physical support and cushioning of the tissue, while serving as a conduit that connects and supports cellular activity.

Are placental-based tissue allograft products FDA regulated?

Placental-based tissue allograft (TA) products are acellular, minimally manipulated tissue allografts and are comprised of tissue allograft components intended for homologous use to supplement tissue. Placental-based tissue allograft products are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public Health Service (PHS) Act. Placental-based tissue allograft products are intended to serve as a scaffold that provides physical support and cushioning to the tissue, while serving as a conduit that connects and supports the recipient’s cells and cellular activity. TAs are intended to be used for repair and reconstruction of the recipient’s tissues consistent with the same basic function or functions in the donor. The FDA recognizes that human tissue was designed, or evolved, to perform certain functions in the human body with exquisite safety and effectiveness. As an HCT/P regulated solely under the Section 361 of the PHS Act, tissue allografts are exempt from FDA pre-market review, clearance, and approval from FDA.

Do Stem Cell Recruitment Therapy® products contain stem cells?

All Stem Cell Recruitment Therapy® products are acellular placental-based tissue allografts that do not contain living, viable stem cells. Placental tissue derived human tissues are classified under FDA 21 CFR 1271 and PHSA Section 361 as a minimally manipulated allograft intended for homologous use.

Is the application of a tissue allograft painful?

There is usually minimal to no pain involved in the application of a tissue allograft, since it is intended for homologous use.

Can I go back to my usual work or daily activities?

Typically you are able to return to work the same day. Your physician will instruct you on any restrictions based on your specific injury.

What does homologous use mean?

Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor (21 CFR 1271.3(c)), including when such cells or tissues are for autologous use. See full definition here: https://www.fda.gov/media/109176/download

Will insurance cover the cost of the tissue allografts?

Yes, but only specific insurance companies do cover these innovative treatment therapies, based on medical necessity. You may pay cash or use your private Health Savings Account (HSA or FSA) to cover these products. Talk with your physician to see if your insurance covers Stem Cell Recruitment Therapy® products.

How many tissue allograft applications are needed?

The number of tissue allografts applications needed depends on the type and severity of your injury. Your physician will determine the number of applications you should receive and the best timeline.

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