Regenerative Medicine Injection Q & A
What is a biologic tissue transplant?
The term “biologics” defines any product derived from living material — human, plant, animal, or microorganism — used for the prevention or cure of disease. Certain tissues can be transplanted and grafted to restore bodily function. The type of transplant selected depends on the purpose of the graft and the anatomic function and availability of the tissue.
What is an Wharton’s Jelly Allograft?
Maragal Medical is proud to offer Wharton’s Jelly Allografts.
Wharton’s Jelly Allograft is minimally manipulated amniotic fluid; it’s a human allograft comprised of amniotic fluid components intended for homologous use to supplement tissue for protection, cushioning, and lubrication. Amniotic fluid functions as a supportive cushion to the fetus and provides a protective environment including rich sources of nutrients, cytokines, and growth factors that are required for fetal development and maturation.
Our lab’s proprietary process preserves the original relevant characteristics of the amniotic fluid. Amniotic fluid possesses anti-inflammatory, anti-microbial and regenerative properties that make it attractive for use in clinical applications.
What are Wharton’s Jelly Allograft injections used for?
Wharton’s Jelly Allograft injections can prompt diseased or dysfunctional tissue to repair itself. These injections are particularly helpful in your:
- Shoulders and elbows
- Wrists, hands, and fingers
- Hips and knees
- Ankles and feet (including plantar fasciitis)
When we inject the Wharton’s Jelly Allograft into an area of your body with damaged soft tissue, the allograft cells replace the damaged tissue with new, healthy tissue. The Wharton’s Jelly Allograft cells have the potential to become regenerative replacements for cells your body loses through wear and tear, injuries, or painful joint conditions. The injection is designed to protect, cushion, and lubricate the damaged soft tissue and/or joint(s).
Additionally, increased scrutiny by various regulatory, accreditation, and professional associations have led to new regulations and standards addressing the issue of tissue management. Our labs products are processed with the highest level of scrutiny possible by the American Association of Tissue Banks.
Our lab’s products are human allografts from donated tissue that comes from women who give birth via Cesarean section delivery. These generous women are tested prior to delivery, and the donated tissue is tested extensively throughout the process.
What sets our lab’s allografts apart?
Surgical procedures using biologic tissues can often improve or enhance your quality of life. As surgical techniques continue to advance, so does the development of biological tissue forms to support these new treatment options. With an increase in options comes an increased need to provide safe, high-quality tissue forms that offer the best clinical outcomes for patients.
Additionally, increased scrutiny by various regulatory, accreditation, and professional associations have led to new regulations and standards addressing the issue of tissue management. Regenerative Labs products are processed with the highest level of scrutiny possible by the American Association of Tissue Banks.
Our lab’s products are allografts, tissue grafted between different or genetically dissimilar individuals of the same species. Our donated tissue comes from women who give birth via Cesarean section delivery. These generous women are tested prior to delivery, and the donated tissue is tested extensively throughout the process.
It’s important to note that biologics are regulated in different ways. Our lab’s products are registered under the standards of the United States Food and Drug Administration.
How are Wharton’s Jelly Allografts regulated?
The main agency tasked with the regulation, quality assurance, and/or accreditation of biologics and tissue allografts is the USFDA:
United States Food and Drug Administration (USFDA)
The USFDA is the regulatory body in the tissue banking industry. Its primary focus is on preventing the transmission of communicable disease associated with the use of donated tissues. Human cells and/or tissue intended for implantation, transplantation, infusion, or transfer into an individual are regulated as human cells, tissues, and cellular and tissue-based products by the Center for Biologics Evaluation and Research (CBER).
Is an Wharton’s Jelly Allograft injection safe?
Yes, Wharton’s Jelly Allografts are safe for most people. The use of biologic tissue transplants offers an improved quality of life for many individuals. As advances in the procurement and processing of biologics continue to evolve, and the numbers and types of biologic tissue forms continue to expand, so do the challenges related to tissue management and compliance with all applicable regulations and guidelines.
Our lab’s products follow all appropriate guidelines for testing as well as processing and ultimately deliver a healthy, viable allograft to patients to promote tissue regeneration. The risks of using our lab’s products are exceptionally small, but a very small risk of disease transmission cannot be 100% ruled out, although no diseases or adverse side effects have ever been reported. With every product there is some risk, and we inform you of all the precautions we take in bringing the product to you, and that a potential risk does exist no matter how small
You may experience temporary, minor pain or swelling in the places where the stem cells are injected. In most cases, irritation or discomfort is minimal.
At Maragal Medical, we are happy to answer all your questions regarding Wharton’s Jelly Allograft injections. Call our office to schedule a consultation.
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