Stem Cells After Peripheral Mobilization and Harvest

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder; Stem Cells
• Intervention / Treatment: Drug: Filgrastim Injection

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Weight 110-220 pounds
• Healthy

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Bone marrow aspirate; 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.

Drug: Filgrastim Injection; Filgrastim of 10 ug/kg/day will be given for four serial days.; Other Names: Neupogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stem Cell Count	Quantity and quality of the harvested stem cells	Baseline to Day 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete blood count	Participants white blood cell count/differential	Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32
Chemokine/Cytokine	Participants chemokine/cytokine count	Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32

Collaborators and Investigators

• Sponsor: Andrews Research & Education Foundation
• Collaborators: Auburn University; Arthrex, Inc.
• Investigators: Principal Investigator: Adam W Anz, MD, Andrews Research & Education Foundation; Study Director: Michael Goodlett, MD, Auburn University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2018
• Primary Completion (ACTUAL): September 4, 2019
• Study Completion (ACTUAL): September 4, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (ACTUAL): December 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: 16398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No