Amniotic Allografts (Stem Cell Injections) Specialist

Gallagher Chiropractic & Medical Wellness

Chiropractors located in Leominster, MA

Amniotic allografts, a type of regenerative medicine, can be an effective treatment option for a variety of osteoarthritic conditions. Gallagher Chiropractic & Medical Wellness and the highly skilled medical team at Maragal Medical in Leominster, Massachusetts, offer this cutting-edge procedure to treat arthritis and joint pain. Men and women who have found little relief from their symptoms rely on the experts at Gallagher Chiropractic & Medical Wellness for amniotic allografts so they can live more pain-free lives. Call to schedule your consultation with our medical wellness team today.

Amniotic Allografts (Stem Cell Injections) Q & A

Gallagher Chiropractic & Medical Wellness

 

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 amniotic allograft?

Gallagher Chiropractic & Medical Wellness and Maragal Medical are proud to offer amniotic allografts (PalinGen® InovoFlo™) from Amnio Technology in Phoenix, Arizona.

An amniotic allograft is minimally manipulated amniotic fluid; PalinGen InovoFlo is 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.

Amnio Technology’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 amniotic allograft injections used for?

Amniotic allograft injections can prompt diseased or dysfunctional tissue to repair itself. When they divide, the allograft can become specialized cells within a particular area of your body. These injections are particularly helpful in your:

  • Spine
  • Shoulders and elbows
  • Wrists, hands, and fingers
  • Hips and knees
  • Ankles and feet (including plantar fasciitis)

When we inject the amniotic allograft into an area of your body with damaged soft tissue, the allograft cells divide and replace the damaged tissue with new, healthy tissue. The amniotic allograft cells have the potential to become regenerative replacements for cells your body loses through wear and tear, injuries, or degenerative diseases like arthritis. The injection is designed to protect, cushion, and lubricate the damaged soft tissue and/or joint(s).

Amniotic allograft injections can also help relieve pain in your joints. For degenerative conditions like arthritis, when we inject the amniotic allograft into your joints and/or soft tissue, the cells can potentially develop into cartilage cells, suppress inflammation, and release proteins to slow down cartilage degeneration.

What sets PalinGen InovoFlo 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 has led to new regulations and standards addressing the issue of tissue management. PalinGen products are processed with the highest level of scrutiny possible by the American Association of Tissue Banks.

PalinGen 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. PalinGen products are registered under the standards of the United States Food and Drug Administration.

How are amniotic allografts regulated?

There are two main agencies tasked with the regulation, quality assurance, and/or accreditation of biologics and tissue allografts:

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).

American Association of Tissue Banks (AATB)

The AATB is an association of organizations dedicated to ensuring that human tissues intended for transplantation are safe and free of infectious disease, of uniformly high quality, and available in quantities sufficient to meet national needs. The AATB’s accreditation program is voluntary.

The “AATB Standards for Tissue Banking” are one step above the standards published by the FDA. Not only do they require donor screening and testing similar to the FDA, but they also focus on the operational and organizational aspects of an organization. The AATB reviews qualifications of tissue bank personnel and the tissue bank’s safety practices, equipment testing, facilities, labeling, and quality assurance programs.

It’s recommended that only allograft tissues supplied by AATB-accredited tissue banks be used. As part of their donor screening process, the AATB requires the following:

  • Complete donor medical and behavioral history data from all pertinent sources, including the most recent medical records
  • Valid, informed consent for donation from the donor’s next-of-kin

In the collection and management of donated tissues, accredited organizations must:

  • Perform tissue recovery using advanced zone and sequencing protocols to decrease the risk of graft contamination
  • Use the most reliable blood testing methods currently available to ensure the minimum risk of transmission of infectious disease
  • Use other information (e.g., autopsy reports) to further ensure allograft safety
  • Use extensive culture analysis of donor tissue before suspending it in antimicrobial solutions
  • Use additional culture analysis as a final step in processing
  • Validate that residual antimicrobials in the treatment solutions do not result in false negative culture results
  • Apply tissue-cleaning processes that further decrease the possibility of disease transmission without causing biological or mechanical harm to the allografts
  • Employ tissue preservation processes that ensure the optimal performance of the allografts after implantation
  • Store and transport the released allografts within temperature and packaging conditions that ensure continuing safety and integrity of the package in which they are sealed
  • Provide documented, routine, in-depth training to technical staff members to ensure knowledge in all of their job responsibilities

Is an amniotic allograft injection safe?

Yes, amniotic 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.

PalinGen 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 PalinGen 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 Gallagher Chiropractic & Medical Wellness, we are happy to answer all your questions regarding amniotic allograft injections. Call our office to schedule a consultation.