Stem CellsPhase 1NCT03381599
Stem Cells After Peripheral Mobilization and Harvest
A Phase 1 study testing Filgrastim Injection in people with Stem Cells and Orthopedic Disorder, run by Andrews Research & Education Foundation at 1 site in United States.
Trial summary
The proposed study is a controlled laboratory study where stem cell content of bone marrow aspirate will be compared prior to and following pharmaceutical mobilization. Participants who meet the inclusion/exclusion criteria will have a bone marrow sample taken from the iliac crest. Read more about this study
- Who is it for?
- Ages 19 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stem Cells, Orthopedic Disorder
- What is being tested?
- Filgrastim Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 4 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight 110-220 pounds
- Healthy
Who cannot join
- Previous allergic reaction to Filgrastim, lidocaine, or other injectable numbing agent
- White blood count greater than 20,000/mcL
- Latex allergy
- Diabetes
- Any autoimmune disorder
- Any blood disorder requiring immunosuppression
Show all 13Show fewer
- Cancer
- Ongoing infectious disease
- Significant cardiovascular, renal, hepatic, or pulmonary disease
- Sickle cell or other blood disorders
- Presence of abdominal tenderness with palpation upon physical examination
- Signs of splenomegaly upon physical examination
- Abnormal lung fields upon physical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification and Qualification of Stem Cells After Peripheral Mobilization and Harvest for Orthopaedic Point of Care Application
The proposed study is a controlled laboratory study where stem cell content of bone marrow aspirate will be compared prior to and following pharmaceutical mobilization. Participants who meet the inclusion/exclusion criteria will have a bone marrow sample taken from the iliac crest. The sample will be tested to determine stem cell content and for the presence of proteins which are of interest in orthopedic treatments. Thirty days following the baseline bone marrow collection, participants will receive a subcutaneous injection of Filgrastim daily for four serial days. On the fifth day, a peripheral blood sample will be taken and processed.
Read the detailed description
Orthopaedic practitioners have begun to augment surgical procedures and treat degenerative conditions, such as osteoarthritis, with injections of bone marrow aspirate. Clinical application studies have suggested that success is dependent upon the number of stem cells harvested and utilized. Pharmaceutical mobilization, with agents such as Filgrastim (Neupogen), followed by peripheral harvest of stem cells has supplanted bone marrow aspirate for hematologic oncologic clinical practice of stem cell transplant, with established safety and efficacy.
The proposed study is a controlled laboratory study where stem cell content of bone marrow aspirate will be compared prior to and following pharmaceutical mobilization using Filmgrastim (Neupogen). Participants will undergo a screening examination consisting of a physical examination and blood work. A standard venipuncture will be performed in the left or right arm and a 5.0 mL vacationer tube will be filled with blood and a 60 mL syringe pre-filled with anticoagulant will be filled with blood. The blood will be analyzed with flow cytometry, a histologic smear, a complete blood count (CBC) with white blood cell (WBC) differential, and chemokine/cytokine analyst with ELISA testing. The blood in the 60.0 mL syringe will be processed with the Arthrex Angel system. The buffy coat component of the blood will be analyzed.
On a separate day, participants who meet the inclusion/exclusion criteria will have a bone marrow sample taken from the iliac crest. The participant will lay on their side and 20 mL of 1% lidocaine will be injected into the anticipated incision site. A 1 cm incision in the skin, advancing a trotter into the bone marrow cavity, aspirating 5 cc of bone marrow with a 5 mL syringe and placement of the sample into a 5 mL vaccutainer syringe, and filling a 60.0 ml syringe pre-filled with 8 ml of citrate anticoagulant with bone marrow aspirate. The bone marrow in the 5 mL vaccutainer will be analyzed by flow cytometry, a histologic smear, a CBC with WBC differential, and chemokine/cytokine analysis with ELISA testing. The bone marrow in the 60.0 mL syringe will be processed with the Arthrex Angel system. The sample will be tested to determine stem cell content and for the presence of proteins which are of interest in orthopedic treatments.
Thirty days following the baseline bone marrow collection, participants will receive a subcutaneous injection of Filgrastim daily for four serial days. A blood sample of 5 mL will be collected each day of the injection to obtain a CBC and WBC differential. On the fifth day, a peripheral blood sample will be taken and processed following the same procedures as the first sample.
It is hypothesized that with a pharmaceutical mobilization method and the Arthrex Angel system, clinicians can harvest more stem cells than with bone marrow aspiration alone.
- Conditions
- Stem Cells, Orthopedic Disorder
- Being tested
- Filgrastim Injection
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filgrastim InjectionDrug
Also called Neupogen
Filgrastim of 10 ug/kg/day will be given for four serial days.
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow aspirate | Experimental | This study will utilize one group of participants. This group of participants will have bone marrow aspirate and a blood sample collected from the iliac crest and subsequently analyzed with the Arthrex Angel system. Thirty days following bone marrow aspiration, participants will receive a subcutaneous Filgrastim injection on four serial days. On the fifth day, a peripheral blood sample sample will be obtained. Receives: Drug: Filgrastim Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stem Cell Count
Quantity and quality of the harvested stem cells
Measured: Baseline to Day 32
Secondary outcomes (2)
Complete blood count
Participants white blood cell count/differential
Measured: Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32
Chemokine/Cytokine
Participants chemokine/cytokine count
Measured: Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start28 Mar 2018
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Auburn University, Arthrex, Inc.
- Responsible party
- Sponsor
- Investigators
- Adam W Anz, MD, Principal investigator, Andrews Research & Education FoundationMichael Goodlett, MD, Study director, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381599
- Sponsor's protocol ID
- 16398
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2017
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification and Qualification of Stem Cells After Peripheral Mobilization and Harvest for Orthopaedic Point of Care Application
- ClinicalTrials.gov ID
- NCT03381599
- Acronym / sponsor ID
- 16398
- Conditions
- Stem Cells, Orthopedic Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- Auburn University, Arthrex, Inc.
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a controlled laboratory study where stem cell content of bone marrow aspirate will be compared prior to and following pharmaceutical mobilization. Participants who meet the inclusion/exclusion criteria will have a bone marrow sample taken from the iliac crest. The sample will be tested to determine stem cell content and for the presence of proteins which are of interest in orthopedic treatments. Thirty days following the baseline bone marrow collection, participants will receive a subcutaneous injection of Filgrastim daily for four serial days. On the fifth day, a peripheral blood sample will be taken and processed.
Detailed description
Orthopaedic practitioners have begun to augment surgical procedures and treat degenerative conditions, such as osteoarthritis, with injections of bone marrow aspirate. Clinical application studies have suggested that success is dependent upon the number of stem cells harvested and utilized. Pharmaceutical mobilization, with agents such as Filgrastim (Neupogen), followed by peripheral harvest of stem cells has supplanted bone marrow aspirate for hematologic oncologic clinical practice of stem cell transplant, with established safety and efficacy.
The proposed study is a controlled laboratory study where stem cell content of bone marrow aspirate will be compared prior to and following pharmaceutical mobilization using Filmgrastim (Neupogen). Participants will undergo a screening examination consisting of a physical examination and blood work. A standard venipuncture will be performed in the left or right arm and a 5.0 mL vacationer tube will be filled with blood and a 60 mL syringe pre-filled with anticoagulant will be filled with blood. The blood will be analyzed with flow cytometry, a histologic smear, a complete blood count (CBC) with white blood cell (WBC) differential, and chemokine/cytokine analyst with ELISA testing. The blood in the 60.0 mL syringe will be processed with the Arthrex Angel system. The buffy coat component of the blood will be analyzed.
On a separate day, participants who meet the inclusion/exclusion criteria will have a bone marrow sample taken from the iliac crest. The participant will lay on their side and 20 mL of 1% lidocaine will be injected into the anticipated incision site. A 1 cm incision in the skin, advancing a trotter into the bone marrow cavity, aspirating 5 cc of bone marrow with a 5 mL syringe and placement of the sample into a 5 mL vaccutainer syringe, and filling a 60.0 ml syringe pre-filled with 8 ml of citrate anticoagulant with bone marrow aspirate. The bone marrow in the 5 mL vaccutainer will be analyzed by flow cytometry, a histologic smear, a CBC with WBC differential, and chemokine/cytokine analysis with ELISA testing. The bone marrow in the 60.0 mL syringe will be processed with the Arthrex Angel system. The sample will be tested to determine stem cell content and for the presence of proteins which are of interest in orthopedic treatments.
Thirty days following the baseline bone marrow collection, participants will receive a subcutaneous injection of Filgrastim daily for four serial days. A blood sample of 5 mL will be collected each day of the injection to obtain a CBC and WBC differential. On the fifth day, a peripheral blood sample will be taken and processed following the same procedures as the first sample.
It is hypothesized that with a pharmaceutical mobilization method and the Arthrex Angel system, clinicians can harvest more stem cells than with bone marrow aspiration alone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone marrow aspirate | Experimental | Drug: Filgrastim InjectionThis study will utilize one group of participants. This group of participants will have bone marrow aspirate and a blood sample collected from the iliac crest and subsequently analyzed with the Arthrex Angel system. Thirty days following bone marrow aspiration, participants will receive a subcutaneous Filgrastim injection on four serial days. On the fifth day, a peripheral blood sample sample will be obtained. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weight 110-220 pounds
- Healthy
Key exclusion criteria (13 listed)
- Previous allergic reaction to Filgrastim, lidocaine, or other injectable numbing agent
- White blood count greater than 20,000/mcL
- Latex allergy
- Diabetes
- Any autoimmune disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filgrastim InjectionAlso: NeupogenFilgrastim of 10 ug/kg/day will be given for four serial days. | Drug | Bone marrow aspirate |
Primary outcome
Change in Stem Cell Count
Time frame: Baseline to Day 32
Quantity and quality of the harvested stem cells
2 secondary outcomes
Complete blood count
Time frame: Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32
Chemokine/Cytokine
Time frame: Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam W Anz, MD principal investigator
Andrews Research & Education Foundation
Michael Goodlett, MD study director
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Filgrastim Injection in people with Stem Cells and Orthopedic Disorder, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stem Cell Count (time frame: Baseline to Day 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.