Stem Cells After Peripheral Mobilization and Harvest
Condition: Stem Cells; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Filgrastim Injection
Intervention type(s): Drug
Intervention description(s): Filgrastim of 10 ug/kg/day will be given for four serial days.
Other intervention name(s): Neupogen
Intervention MeSH terms: Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other