Stem Cells After Peripheral Mobilization and Harvest

NCT03381599 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 16398
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stem Cells; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Stem Cell Count

  Quantity and quality of the harvested stem cells

  Baseline to Day 32

Secondary Outcomes (2)

• Complete blood count

  Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32

• Chemokine/Cytokine

  Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32

Study Arms (1)

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.

Drug: Filgrastim Injection

Interventions

Filgrastim Injection DRUG

Filgrastim of 10 ug/kg/day will be given for four serial days.

Also known as: Neupogen

Bone marrow aspirate

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weight 110-220 pounds
• Healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• Auburn University: collaborator
• Arthrex, Inc.: collaborator

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Adam W Anz, MD

  Andrews Research & Education Foundation

  PRINCIPAL INVESTIGATOR

• Michael Goodlett, MD

  Auburn University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 22, 2017
• Study Start: March 28, 2018
• Primary Completion: September 4, 2019
• Study Completion: September 4, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)