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Adipose-derived preparations

Also: fat-derived preparations

A broad description of preparations made from adipose tissue, the tissue that stores fat.

Adverse event

Also: AE

An unwanted health occurrence during treatment or research, whether or not it is shown to have been caused by the intervention.

Allogeneic

Also: allogenic

From another individual of the same species, rather than from the recipient.

Amniotic tissue

Also: amnion, amniotic membrane

Tissue from the amnion, the inner fetal membrane surrounding the developing baby during pregnancy.

Aspiration

In a procedure description, withdrawal of fluid or tissue through a needle.

Autologous

Taken from the same person who will receive the material.

Biologic

Also: biological product, biologics

A broad product category that includes materials such as vaccines, blood components, proteins, cells and tissues derived from biological sources.

Blinding

Also: masking, blinded study

Keeping the assigned treatment unknown to specified people in a study, such as participants or those assessing outcomes.

Board certification

Also: board certified

A credential awarded by a named certifying board after its requirements in a specialty or area of practice are met.

Bone marrow aspirate

Also: BMA

The liquid material withdrawn from inside a bone during bone marrow aspiration.

Bone marrow aspirate concentrate

Also: BMAC, BMC

A preparation made by processing bone marrow aspirate to concentrate selected components, commonly using a centrifuge.

Bone marrow aspiration

A procedure that withdraws liquid marrow from inside a bone using a needle.

Cell count

Also: cell number

A measurement of how many cells are present in a sample or specified volume.

Cell viability

Also: viable cells

An assessment of whether cells are alive according to the measurement method used.

Centrifugation

Also: centrifuge processing

Spinning a sample to help separate its components.

Clinical significance

Also: clinical importance, clinically meaningful change

The practical importance of a result for health, function or the decisions patients face.

Clinical trial

A research study in people that evaluates a health intervention, such as a treatment, prevention strategy or diagnostic approach.

Complication

An additional medical problem that occurs during a disease, treatment or procedure.

Contraindication

A circumstance that makes a particular treatment or procedure inadvisable because of potential harm.

Control group

Also: comparison group

The group used as a comparison when assessing an intervention in a study.

Cryopreservation

Also: frozen storage

Preservation of cells, tissues or other biological material at very low temperatures.

Deductible

An amount you pay for covered care before your plan begins paying for services subject to that deductible.

Donor-derived

Also: donor material

Describes material obtained from a donor; the wording should be followed by details identifying the source and relationship to the recipient.

Establishment registration

Also: FDA registration

Submission of establishment information to FDA under the registration requirements that apply to its activities.

Exosomes

Also: exosome

A type of extracellular vesicle formed within cells and released outside them, carrying some cellular material.

Expanded access

Also: compassionate use

A pathway for treatment use of an investigational product outside a clinical trial when the applicable eligibility and oversight requirements are met.

Extracellular vesicles

Also: EVs

Membrane-enclosed particles released by cells into their surroundings.

FDA approval

An FDA decision allowing a product to be marketed under the applicable approval pathway for specified uses.

FDA authorization

A context-dependent term for FDA permission under a particular pathway, such as an emergency use authorization.

FDA clearance

Also: 510(k) clearance

A device marketing decision commonly associated with FDA’s 510(k) substantial-equivalence pathway.

FDA warning letter

An FDA communication notifying a recipient of violations the agency considers significant and seeking corrective action.

Fibrin

A protein formed from fibrinogen during blood clotting that helps create the clot structure.

Financial conflict of interest

A situation in which a financial interest could influence, or appear to influence, professional judgment or research interpretation.

Fluoroscopy-guided procedure

Also: fluoroscopic guidance

A procedure guided by a sequence of X-ray images that helps show anatomy and instrument placement.

Follow-up

Also: follow-up care

Care or assessment after an initial visit or treatment to check progress and identify further needs.

Growth factor

Also: growth factors

A substance involved in regulating processes such as cell division and survival.

Hematopoietic stem cells

Also: HSCs, blood-forming stem cells, blood stem cells

Stem cells that can develop into blood cells, including red cells, white cells and platelets.

Homologous use

In FDA’s human-cell and tissue framework, use in which the recipient’s tissue or cells perform the same basic function as in the donor.

Indication

A condition, sign or symptom that provides a reason to consider a test, treatment or procedure.

Informed consent

A process of receiving and discussing relevant information before deciding whether to agree to a medical procedure or research participation.

Injectable PRF

Also: i-PRF, injectable platelet-rich fibrin

A platelet-rich fibrin preparation collected while it is still liquid so it can be delivered by injection before clotting.

Injection

Also: shot

Delivery of a fluid or medicine into the body with a needle and syringe.

Institutional review board

Also: IRB

A committee that reviews human-subject research with responsibility for protecting participants’ rights and welfare.

Insurance network

Also: provider network, in network

The providers, facilities and suppliers contracted with a health plan to deliver services to its members.

Intra-articular injection

Also: joint injection

An injection delivered into the space within a joint.

Intratendinous injection

An injection delivered into a tendon.

Investigational new drug application

Also: IND

A submission to FDA supporting investigation of a drug or biological product in people under the applicable rules.

Leukocyte-poor PRP

Also: LP-PRP

Platelet-rich plasma prepared with relatively fewer leukocytes, or white blood cells.

Leukocyte-rich PRP

Also: LR-PRP

Platelet-rich plasma prepared with a relatively higher concentration of leukocytes, or white blood cells.

Local anesthesia

Also: local anaesthesia, local anesthetic

Temporary numbing of a small area with an anesthetic medicine while the person remains awake.

Mesenchymal stromal cells

Also: MSCs, multipotent mesenchymal stromal cells

A cell population characterized in research using features such as attachment in culture, cell markers and laboratory differentiation tests.

Meta-analysis

A statistical method for combining results from two or more studies.

Microfragmented adipose tissue

Also: MFAT, mFAT, MF-AT

Adipose tissue processed mechanically into smaller tissue fragments for a proposed clinical use.

Minimal manipulation

A regulatory concept concerning how processing affects the relevant characteristics of cells or tissues.

National Provider Identifier

Also: NPI

A ten-digit identifier used to identify health care providers in standard administrative transactions.

Off-label use

Also: unapproved use of an approved drug

Use of an approved product in a way outside its approved labeling; FDA’s patient guide explains this in the context of approved drugs.

Orthobiologics

Also: orthopaedic biologics, orthopedic biologics

An umbrella term for biologically derived materials used or studied in musculoskeletal care.

Osteoarthritis

Also: OA

A joint disease involving changes in cartilage and other joint tissues that can cause pain, stiffness and difficulty with movement.

Out-of-pocket cost

Also: out-of-pocket costs, patient responsibility

The portion of medical expenses that you pay and that is not reimbursed by insurance.

Outcome measure

Also: study outcome, endpoint

A defined measurement used to assess what happens during or after a study intervention.

Peer review

Assessment of a research manuscript by people with relevant expertise as part of a journal publication process.

Peritendinous injection

An injection delivered around a tendon rather than within the tendon itself.

Placebo

An inactive substance or comparison intervention designed to resemble the treatment being tested.

Placental tissue

Tissue obtained from the placenta, the organ that supports the developing fetus during pregnancy.

Plasma

Also: blood plasma

The liquid portion of blood in which blood cells and platelets are carried.

Platelet

Also: thrombocyte, platelets

A small cell fragment in blood that helps with clot formation and responses to injury.

Platelet concentration

Also: platelet count per volume

The number of platelets in a specified volume of a preparation.

Platelet lysate

Also: PL, human platelet lysate, hPL

Material containing substances released when platelets are broken open.

Platelet-rich fibrin

Also: PRF

A preparation made from blood in which platelets are associated with a fibrin network that forms as the blood clots.

Platelet-rich plasma

Also: PRP

A blood preparation in which platelets are concentrated in plasma, usually from the person receiving it.

Prior authorization

Also: preauthorization, precertification

A health plan’s review or approval that may be required before a service, treatment or medicine is provided.

Professional licensure

Also: professional license, professional licence

Permission from the relevant licensing authority to practice a regulated profession within its jurisdiction and applicable conditions.

Prolotherapy

Also: proliferation therapy

An injection approach intended to provoke a local tissue response, often described in terms of repeated injections of an irritant solution.

Randomized controlled trial

Also: RCT, randomised controlled trial

A study that assigns participants by chance to intervention and comparison groups.

Regenerative consultation

Also: regenerative medicine consultation

A clinic visit to discuss a condition and options described by the clinic as regenerative medicine.

Regenerative medicine

A broad area of research and care concerned with replacing, repairing or supporting damaged cells and tissues.

Rehabilitation

Also: rehab

Care intended to help a person restore, maintain or adapt physical abilities and daily function.

Risk-benefit assessment

Also: benefit-risk assessment

Consideration of possible benefits, harms and uncertainties when comparing care options.

Sample size

Also: number of participants

The number of participants or other units included in a study or analysis.

Scope of practice

The activities a professional is permitted and qualified to perform within the applicable regulatory framework.

Second opinion

Also: another opinion

An assessment by another clinician about a diagnosis or proposed plan of care.

Self-pay

Also: cash pay, paying without insurance

Paying for care without using health insurance to cover that service.

Shared decision-making

Also: shared decision making, SDM

A discussion in which a patient and clinician compare options using evidence and the patient’s priorities.

Side effect

An effect of a medicine or treatment in addition to its intended effect.

Specialty training

Education and supervised experience focused on a particular area of clinical practice.

Standard of care

Also: standard treatment

Care that medical experts generally accept as appropriate for a particular condition or situation.

Statistical significance

A conventional label applied when a statistical test result meets a chosen threshold under its assumptions.

Stem cells

Also: stem cell

Cells that can give rise to other cell types; different kinds have different developmental capabilities.

Stromal vascular fraction

Also: SVF

A heterogeneous cell fraction separated from adipose tissue, containing several cell populations rather than a single purified stem-cell type.

Systematic review

A review that uses a defined question and explicit methods to find, select and assess relevant studies.

Tendinopathy

Also: tendon disorder

A term used for a tendon condition involving pain and impaired function, often associated with repeated loading.

Trial registration

Also: study registration, NCT number

Creation of a public record describing a research study in a registry such as ClinicalTrials.gov.

Ultrasound-guided procedure

Also: ultrasound guidance

A procedure in which real-time ultrasound images help a clinician locate anatomy and guide an instrument or needle.

Umbilical cord tissue

Also: cord tissue

Tissue from the cord connecting a fetus to the placenta, including several distinct structural regions.

Wharton's jelly

Also: Wharton jelly

The gelatinous connective tissue surrounding blood vessels within the umbilical cord.

Written estimate

Also: cost estimate

A written statement of the charges expected for described care, with enough detail to understand what is included.