A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
Condition: Foot Deformities, Acquired; Disorder of Joint of Foot; Fracture of Foot; Deformity of Bone
MeSH terms: Foot Deformities; Foot Deformities, Congenital; Joint Diseases; Foot Deformities, Acquired; Congenital Abnormalities
Intervention: map3
Intervention description: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle.
      Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem
      cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed
      an informed consent, the baseline visit and examinations will be completed. Patients will be
      evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study subjects will be limited to patients with foot/ankle pathologies requiring
             fusion, which include midfoot, hindfoot, ankle, double and triple arthrodesis using
             open surgical technique with supplemental bone graft substitute.

          -  Life expectancy of at least twenty four (24) months

          -  Ability to give written informed consent

          -  All subjects will have a minimum age of eighteen (18) years and a maximum of eighty
             (80) years.

          -  Both male and non-pregnant female subjects will be included.

          -  To facilitate follow-up, study subjects will be limited to the local geographic area
             of the study site and must be willing to use the rehabilitation facility and physical
             therapy schedule assigned by the surgeon.

          -  All subjects must be able to read, write, and comprehend instructions and guidelines
             in English and understand (and sign as an acknowledgment of their understanding) an
             informed consent declaration

        Exclusion Criteria:

          -  Patients who have been diagnosed with Charcot foot

          -  Patients requiring osteotomies or undergoing a revision surgery for non-union

          -  Patients with additional lower limb injuries requiring concomitant procedures not
             related to the current foot/ankle procedure

          -  Patients with soft tissue compromise involving open and/or infected wounds on the
             study limb

          -  Patients requiring any other bone grafting product other than study product (map3®
             Cellular Allogeneic Bone Graft) e.g. rhBMP2 (recombinant human bone morphogenetic
             protein 2).

          -  Patients with confirmed diagnosis of abnormal lower limb vasculature or peripheral
             vascular disease

          -  Patients with a high Body Mass Index ( BMI > 35)

          -  Diagnosis of osteonecrosis, metabolic bone diseases or gout

          -  Diabetic patients who are insulin dependent

          -  Patients who have received any treatment within the past 12 months which may interfere
             with bone metabolism (bisphosphonates and/or calcitonin).

          -  Patients using glucocorticoids > 10 mg/day

          -  Chronic use (≥ 90 days) of non-steroidal anti-inflammatory drugs (NSAIDS)

          -  Patients with active cancer or a history of any cancer

          -  Known allergies to Dimethyl Sulfoxide (DMSO) and/or Human Serum Albumin (HSA)

          -  Pregnant or lactating females or who are capable of reproduction and will not take
             acceptable measures to prevent reproduction during the study

          -  Patients who have tested positive for HTLV, HIV, hepatitis B or hepatitis C, have
             rheumatoid arthritis, an autoimmune disease or are on chronic immunosuppressive
             medications

          -  Require chronic use (≥ 90 days) of anticoagulation therapy

          -  Active smokers unwilling to comply with surgeons instructions to stop smoking seven
             (7) days prior to surgery through three (3) month post-op visit

          -  History of alcohol or drug abuse within 90 days of screening

          -  Patients currently enrolled or have been enrolled in clinical studies evaluating
             investigational devices, pharmaceuticals or biologics within 90 days of enrollment.

          -  Patients unable to give written informed consent and any vulnerable patient population

          -  Inability to comply with all requirements of this investigation, as well as follow the
             instructions of the physician