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The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the last collection.
This is a prospective, randomized, cross-over, multi-center study to evaluate the performance of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra system's MNC Procedure in mobilized healthy donors.
Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects. Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE Spectra MNC collection procedure first, followed by the opposite on the following day.
Study participation will be up to 14 days: a 7-day screening period, four days for mobilization, one day for the first MNC collection with additional dose of mobilization, one day for the second MNC collection, and safety follow-up the following day.
Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the second collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectra Optia CMNC first, then COBE Spectra MNC | Experimental | Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure. |
|
| COBE Spectra MNC first, then Spectra Optia CMNC | Experimental | COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectra Optia CMNC | Device | The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood. |
| Measure | Description | Time Frame |
|---|---|---|
| CD34+ Collection Efficiency (CE1 %) | The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | within 5 minutes upon completion of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| CD34+ Collection Efficiency (CE2 %) | Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Deficiencies | Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner. |
Inclusion Criteria:
≥ 18 and ≤ 50 years of age
Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)
a) Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study
Adequate dual peripheral venous access
Acceptable prescreening laboratory results prior to MNC mobilization as specified below:
a) WBC 3,500 - 10,800/µL
b) Hematocrit 38% - 56%
c) Platelets 150,000 - 400,000/µL
d) Coagulation tests:
i. PT 9.0 - 13.0 seconds
ii. PTT 23.4 - 41.8 seconds
e) Serum electrolytes:
i. Potassium 3.6 - 5.1 mmol/L
ii. Serum Calcium 8.5 mg/dL - 10.3 mg/dL
f) Renal function: Serum creatinine ≤ 1.5 mg/dL
NOTE: up to two laboratory results may fall out of the ranges listed above if, in the judgment of the investigator, they do not constitute a significant risk to the subject.
Liver function: alanine aminotransferase (ALT) < 1.5 times the upper limit of normal
Willing to avoid pregnancy until at least 48 hours following last G-CSF injection
Given written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Goodrich, PhD | Terumo BCT | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoxworth Blood Center | Cincinnati | Ohio | 45267-0055 | United States | ||
| Key Biologics, LLC |
A lead-in phase was used to allow for investigational device training. One subject consented the lead-in phase and was included in the safety analysis only. After a screening period to evaluate and confirm eligibility criteria prior to enrollment & randomization to treatment assignment (Arm 1 or Arm 2) 22 subjects enrolled in the pivotal study.
Subjects were recruited from the specialized donor population of blood centers from August 2014 through January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lead-in Donor | Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only. |
| FG001 | Spectra Optia CMNC First, Then COBE Spectra MNC | Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure. Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood. COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled. |
| FG002 | COBE Spectra MNC First, Then Spectra Optia CMNC | COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure. Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood. COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy adult specialized blood donors
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lead-in Donor | Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only. |
| BG001 | Spectra Optia CMNC First, Then COBE Spectra MNC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CD34+ Collection Efficiency (CE1 %) | The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | Posted | Mean | Standard Deviation | percent | within 5 minutes upon completion of procedure |
|
AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-collection | Subjects screened and received G-CSF. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer - BBT | Terumo BCT | 303-232-6800 | Ray.Goodrich@terumobct.com |
Not provided
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
|
| COBE Spectra MNC | Device | It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled. |
|
|
| Granulocyte-colony stimulating factor (G-CSF) | Drug | Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure. |
|
|
| within 5 minutes upon completion of procedure |
| MNC Collection Efficiency (CE1%) | Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | within 5 minutes upon completion of procedure |
| CD34+ Per kg of Body Weight | within 5 minutes upon completion of procedure |
| MNC Product Contamination/Purity (%) - Hematocrit (%) | within 5 minutes upon completion of procedure |
| MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL) | within 5 minutes upon completion of procedure |
| MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL) | within 5 minutes upon completion of procedure |
| MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %) | Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | within 5 minutes upon completion of procedure |
| MNC Blood Product Volume (mL) | The produced unit of MNCs collected into the blood bag. | within 5 minutes upon completion of procedure |
| Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL) | A small amount of plasma typically used for processing was collected in a sub-set of collection procedures. | within 5 minutes upon completion of procedure |
| Procedure Time (Minutes) | within 5 minutes upon completion of procedure |
| MNC Collection Efficiency (CE2%) | Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | within 5 minutes upon completion of procedure |
| MNC Product Contamination/Purity - RBC Concentration (10^6/µL) | within 5 minutes upon completion of procedure |
| 24-hours after last collection procedure |
| Post-collection Platelet Loss in Subject | The percent change from pre-collection platelet count to post-collection subject platelet count. | 24-hours after last collection procedure |
| Memphis |
| Tennessee |
| 38104 |
| United States |
Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.
| BG002 | COBE Spectra MNC First, Then Spectra Optia CMNC | COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure. Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood. COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | inches |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Treatment Assignment 2 | COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure. Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood. COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled. |
|
|
| Secondary | CD34+ Collection Efficiency (CE2 %) | Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | Posted | Mean | Standard Deviation | percent | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | MNC Collection Efficiency (CE1%) | Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated. | Posted | Mean | Standard Deviation | percent | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | CD34+ Per kg of Body Weight | Posted | Mean | Standard Deviation | cells/kg | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | MNC Product Contamination/Purity (%) - Hematocrit (%) | Posted | Mean | Standard Deviation | % of red blood cells | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL) | Posted | Mean | Standard Deviation | cells*10^3/mL | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL) | Posted | Mean | Standard Deviation | cells*10^3/µL | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %) | Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated. | Posted | Mean | Standard Deviation | percent | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | MNC Blood Product Volume (mL) | The produced unit of MNCs collected into the blood bag. | Posted | Mean | Standard Deviation | mL | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL) | A small amount of plasma typically used for processing was collected in a sub-set of collection procedures. | Five collections also collected plasma for this sub-study. | Posted | Mean | Standard Deviation | cells*10^3/µL | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | Procedure Time (Minutes) | Posted | Mean | Standard Deviation | minutes | within 5 minutes upon completion of procedure |
|
|
|
| Other Pre-specified | Device Deficiencies | Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner. | All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis. | Posted | Number | events | 24-hours after last collection procedure |
|
|
|
| Other Pre-specified | Post-collection Platelet Loss in Subject | The percent change from pre-collection platelet count to post-collection subject platelet count. | Posted | Mean | Standard Deviation | percent change | 24-hours after last collection procedure |
|
|
|
| Secondary | MNC Collection Efficiency (CE2%) | Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected. | Posted | Mean | Standard Deviation | percent | within 5 minutes upon completion of procedure |
|
|
|
| Secondary | MNC Product Contamination/Purity - RBC Concentration (10^6/µL) | Posted | Mean | Standard Deviation | RBC*10^6/µL | within 5 minutes upon completion of procedure |
|
|
|
| 0 |
| 23 |
| 22 |
| 23 |
| EG001 | Spectra Optia | Subject who received Spectra Optia CMNC collection procedure. | 0 | 23 | 13 | 23 |
| EG002 | COBE Spectra | Subjects who received COBE Spectra MNC collection procedure. | 0 | 22 | 16 | 22 |
| EG003 | Follow up | Subjects who completed cross-over design and were followed for at least 1 day. | 0 | 23 | 2 | 23 |
| fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| hemoglobin decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| platelet count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| paraesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| palpitations | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypoaesthesia oral | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| abdominal pain lower | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| infusion site extravasation | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| injection site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| musculoskeletal pain | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| peripheral sensory neuropathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| tension headach | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| insomina | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| restlessness | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
Not provided
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |