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Results for “TISSUE THERAPY”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 19 recordsLinked to original sources
PubMed2003

Current regulatory issues in cell and tissue therapy.

Cell-based therapies have grown dramatically in power and scope in recent years. Once limited to blood and BM transplantation, these therapies now encompass tissue repair and regeneration, metabolic support, gene replacement, and immune effector functions, with established and investigational clinical applications in disorders affecting nearly every tissue and organ system. The complexity and novel applications of human cells, tissues, and cellular and tissue-based products (HCT/Ps), however, present potential risks for adverse events. The US Food and Drug Administration, responding to these concerns, has established a tiered, risk-based regulatory structure, in which more rigorous controls and safeguards are required for products thought to pose increased risk. The proposed good tissue practices (GTP) rule and existing good manufacturing practices (GMP) requirements form the principal elements of this regulatory framework. The proposed GTPs are intended to prevent HCT/P contamination with infectious disease agents, and to ensure that these cells and tissues maintain their integrity and function. GMPs focus on production of safe, pure, and potent products, and entail a higher level of process control and product characterization. All HCT/Ps will be required to comply with GTPs. HCT/Ps considered to present greater risks of adverse events, however, will be subject to both GTPs and GMPs, and must obtain premarket approval using the Investigational New Drug (IND) mechanism established for biologics. Although these requirements will present significant challenges for clinician- investigators and laboratories producing HCT/Ps, the regulations fundamentally support good clinical care by increasing safety and control, and enable good science by improving the quality and reliability of data.

Accreditation↗
PubMed1994

[The immunological aspects of the pathogenesis and specific tissue therapy of trigeminal neuralgia].

The authors suggest a new pathogenetic mechanism working in some forms of trigeminal [correction of trifacial] neuralgia. The mechanism is based on autoimmune reactions, notably, abolition of natural immunologic tolerance to normal proteins of neuronal conduction structural elements and appearance of pathological autoantibodies to them. A new pathogenetic therapy is validated: tissue treatment with preserved cadaveric femoral nerve. A therapeutic response to the above therapy may arise due to recovered immunologic tolerance to normal neuroproteins, immunomodulating action on the basic components of the immune status, specific intracorporeal immunosorption of pathological autoantibodies on nerve transplants.

Autoantibodies↗
PubMed1954

[Tissue therapy].

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Cell- and Tissue-Based Therapy↗
PubMed1954

[Tissue therapy].

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Cell- and Tissue-Based Therapy↗
PubMed1955

[Tissue therapy].

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Cell- and Tissue-Based Therapy↗