Stem Cells After Peripheral Mobilization and Harvest

NCT ID: NCT03381599

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2019-09-04

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Filgrastim Injection

Intervention Type: DRUG

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

Interventions

Filgrastim Injection

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

Intervention Type: DRUG

Other Intervention Names

Neupogen

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Auburn University

OTHER

Sponsor Role: collaborator

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

Andrews Research & Education Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam W Anz, MD

Role: PRINCIPAL_INVESTIGATOR

Andrews Research & Education Foundation

Michael Goodlett, MD

Role: STUDY_DIRECTOR

Auburn University

Locations

Auburn University

Auburn, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

16398

Identifier Type: -

Identifier Source: org_study_id