Schedule a call Call720-550-6175

The regulations behind our services

Biologics under FDA guidelines.

We have followed FDA rules for cell and tissue products since Boulder Biologics opened. Those rules have been clarified as the field has changed, and this page explains how they apply to what we do.

Key FDA definitions

HCT/Ps and the regulatory vocabulary.

Human cells, tissues, and cellular and tissue-based products (HCT/Ps) comprise human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. The pertinent FDA definitions follow.

Structural Tissues

FDA classification

Tissues that physically support or serve as a barrier or conduit, or connect, cover or cushion in the donor are generally considered structural tissues for the purposes of determining the applicable regulatory definition. Examples of structural tissues include bone, skin, amniotic membrane and umbilical cord, blood vessel, adipose tissue, articular cartilage, non-articular cartilage, and tendon or ligament.

Cells and Nonstructural Tissues

FDA classification

Cells or nonstructural tissues are generally those that serve predominantly metabolic or other biochemical roles in the body, such as hematopoietic, immune, and endocrine functions. Examples of nonstructural tissues include reproductive cells or tissues, hematopoietic stem/progenitor cells, lymph nodes and thymus, parathyroid glands, peripheral nerve, and pancreatic tissue.

Minimal Manipulation

21 CFR 1271.3(f)
  • Structural tissue: processing that does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement.
  • Cells or nonstructural tissues: processing that does not alter the relevant biological characteristics of cells or tissues.

Homologous Use

21 CFR 1271.3(c)

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.

Same Surgical Procedure Exception

21 CFR 1271.15(b)

For the exception to apply, an establishment must:

  • Remove and implant the HCT/Ps into the same individual from whom they were removed (autologous use).
  • Implant the HCT/Ps within the same surgical procedure.
  • The HCT/Ps remain "such HCT/Ps;" they are in their original form. Generally, to remain "such HCT/Ps," the only processing steps are rinsing, cleansing, sizing, and shaping.

Section 361 of the PHS Act & 21 CFR 1271.10(a)

When the FDA does not require premarket approval.

Under section 361 of the PHS Act, a cell or tissue product (HCT/P) is regulated as tissue, without FDA premarket approval, when it meets all of the criteria in 21 CFR 1271.10(a):

  1. The HCT/P is minimally manipulated.
  2. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent.
  3. The manufacture of the HCT/P does not involve the combination of the 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 the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P.

And either:

  • The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function, or
  • The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and is for autologous use, allogeneic use in a first-degree or second-degree blood relative, or reproductive use.

In practice

Here is how we prepare and use your own tissue.

Our lab prepares your own blood, bone marrow, and fat tissue for use in your procedure, using processing we consider minimally manipulated under the FDA's definition. It follows the current Good Tissue Practice (cGTP) guidelines as described in the Code of Federal Regulations (CFR) title 21, part 1271. These materials are obtained from the patient (autologous) and include whole blood, bone marrow aspirate, and adipose tissue for orthopedic joint-related procedures. The FDA-defined structural and cell/nonstructural products used at Boulder Biologics are:

  • Structural: autologous adipose
  • Nonstructural / Cell: autologous bone marrow aspirate

Cellular therapies are processed at Boulder Biologics using minimal manipulation in accordance with 21 CFR 1271.3(f). We concentrate your blood and bone marrow by spinning them in a centrifuge, which separates the layers by density. A small amount of anticoagulant (ACD-A for blood; heparin and ACD-A for bone marrow) keeps the samples from clotting. Bone marrow is passed through a sterile filter before it is concentrated for injection or used for an infusion.

Adipose tissue harvested for orthopedic procedures undergoes a short centrifugation process to remove excess saline used in the harvest infiltration process. We use your own fat tissue only by injection, and only to cushion and support a structural area. We have never given fat tissue by IV or through the nose.

Cellular and tissue therapies at Boulder Biologics are all performed under homologous use, 21 CFR 1271.3(c). All cellular and tissue therapies are also harvested, processed, and applied during the same procedure; therefore, the same surgical procedure exception in 21 CFR 1271.15(b) applies, and the requirements in 21 CFR Part 1271 are not applicable.

If you have questions about how we follow these rules, call us at 720-550-6175 or ask at your consultation.

References

FDA source documents.

  1. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use. U.S. Food and Drug Administration. fda.gov/regulatory-information/...minimal
  2. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception. U.S. Food and Drug Administration. fda.gov/media/89920/download
  3. Regulatory considerations for HCT/Ps: minimal manipulation and homologous use, guidance for industry and FDA staff. U.S. Food and Drug Administration. fda.gov/media/109176/download
  4. 21 CFR Part 1271 Subpart D, Current Good Tissue Practice. Electronic Code of Federal Regulations. ecfr.gov/current/title-21/.../subpart-D

Schedule a call

Ask us how we prepare your tissue.

Dr. Glowney and the team are happy to walk you through how we harvest, process, and deliver autologous biologic material, and how that aligns with current FDA guidance.

720-550-6175
Submitting this form does not establish a patient-provider relationship.