FDA Final Guidance document for our HCTP industry 

On November 17, 2017, the FDA published a long-awaited Final Guidance document for our HCTP industry. The document, Regulatory Considerations for Human Cells, Tissues, and Cellular and TissueBased Products: Minimal Manipulation and Homologous Use, finalized the FDA’s thinking on some of the misunderstandings that exist in relation to Minimal Manipulation and Homologous Use. Utah Cord Bank has analyzed the various FDA Guidance Documents recently finalized and want to ensure you and our customers that we are in full compliance. 



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UTAH CORD BANK Stem Cell Release

Purpose

The purpose of this document is to provide the manufacturer’s objective for Utah Cord Bank’s (UCB) products.

Background

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for transplantation, infusion or transfer into a human recipient. UCB produces two products, StemShot® and StemVive™. These products are processed from postnatal birth tissue received from eligible donors, consisting of umbilical cord blood and cells recovered from the placenta.

The use of the terminology, manufacturer’s objective intent, is found throughout HCT/P related documents, papers, standards and regulations. To help better define what this statement means, the FDA published a Guidance Document in November 2017, Regulatory Considerations for Human Cells, Tissues and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. In Section IV, Question 22 – What does FDA mean by “manufacturer’s objective intent” in 21 CFR 1271.10(a)(2), the answer below is provided:

A manufacturer’s objective intent is determined by the expressions of the manufacturer or its representatives, or may be shown by the circumstances surrounding the distribution of the article. A manufacturer’s objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by the manufacturer or its representatives. It may be shown by the circumstances that the HCT/P is offered for a purpose for which it is neither labeled nor advertised.

Manufacturer’s Objective Intent

Based on a review of the regulations and FDA guidance documents, Utah Cord Bank, Inc., the manufacturer of StemShot® and StemVive™ have defined the manufacturer’s objective intent below.

The primary function of the StemShot® and StemVive™ products are to supplement the recipient’s tissue and assist in the body’s natural regenerative functions. These products are intended for homologous use, on a single patient, one time use only and are used by licensed medical professionals (e.g., physician) on unrelated, allogeneic patients and may not be modified or mixed.

These products are cells / nonstructural tissues that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune and endocrine functions. Both StemShot® and StemVive™ are minimally manipulated and are processed from postnatal birth tissue received from eligible donors, consisting of umbilical cord blood and cells recovered from the placenta.

All marketing material, advertising and communication from representatives from UCB shall be in alignment with this intent at all times and the products shall not be offered for any purpose for which they are neither labeled nor advertised.

 

Purpose

The purpose of this document is to provide Utah Cord Bank’s (UCB) compliance rationale for the US FDA’s definition of minimal manipulation.

Background

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for transplantation, infusion or transfer into a human recipient. UCB produces two products, StemShot® and StemVive™. These products are processed from postnatal birth tissue received from eligible donors, consisting of umbilical cord blood and cells recovered from the placenta.

StemShot® and StemVive™ are minimally manipulated human tissue flowable allograft products intended for homologous use only. The processing of these products aligns with the minimal manipulation requirements identified by the FDA to ensure they are free from potential contaminants or harmful components. Further, the processing of the products does not alter the relevant biological characteristics of cells or tissues.

Primary Function of UCB Products

The primary function for StemShot® and StemVive™ is to supplement the recipient’s tissue and assist in the body’s natural regenerative functions.

UCB’s Minimal Manipulation Compliance Rationale

Based on an evaluation of FDA regulations, FDA Guidance Documents (e.g., Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, November 2017, and Tissue Reference Group (TRG) documents, Utah Cord Bank’s products are minimally manipulated and align to the regulatory factors in the table below.

Minimal Manipulation Compliance Rationale

UCB Products Are

UCB Products Are Not

Cells or nonstructural tissues that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune and endocrine functions (FDA Guidance Document – Minimal Manipulation of HCT/P).

Processed in any way that alters relevant biological characteristics of cells or nonstructural tissues (21 CFR 1271.3(f)(2)).

Intended for homologous use to supplement the recipient’s tissue and assist in the body’s natural regenerative functions (StemShot and StemVive instructions for use).

Manufactured in any way that involves the combination of cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or a sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P (21 CFR 1271.10(a)(3).

Intended for homologous use only, as reflected by the labeling, advertising or other indications of the manufacturer’s objective intent (21 CFR 1271.10(a)(2)).

Dependent on having a systemic effect upon the metabolic activity of living cells for its primary function (21 CFR 1271.10(a)(4)(i)).

Minimally manipulated via processing procedures that include separation, cutting, grinding and shaping (FDA Guidance Document – Minimal Manipulation of HCT/P).

Incubated in a laboratory vessel where the processing affects the production of intracellular or cell-surface proteins or other markers of cell lineage, activation state and proliferation, thereby altering the cells’ biological characteristics of multipotency and capacity for self-renewal (FDA Guidance Document – Minimal Manipulation of HCT/P).

Contact Information:

Providers Looking for related information or products call 972-800-6670

Consumers looking for educational Information regarding stem cells visit http://www.iSTEMCELL.com

Industry News:

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Labs, Scientests, Politicians,Big-Pharma are all watching stemcells very carfully and working on ways to bring them into the fold!