CLINICAL STUDIES IN PROGRESS

HIP

hip

STUDY DESIGN

Patients will be treated for Osteoarthritis (OA) of the hip due to degeneration or chronic injury. They will be treated with autologous StroMed and Platelet Rich Plasma (PRP) processed as a direct injection to the affected joint. Patient outcomes will be tracked with laboratory tests.

PATIENT INTAKE

Prior to scheduling the patient is screened by the doctor. All inclusion and exclusion criteria are considered and patient intake is done at this time. Images are evaluated. At this time, the entire procedure is reviewed with the patient.

AIM

The purpose of this study is to quantifiably determine if the proposed protocol, an intra-articular injection with a combination of StroMed and PRP, has a significant clinical effect on pain and inflammation associated with Osteoarthritis of the hip. Also, by obtaining MRI’s at 0 and 6 months, we hope to see early evidence of re-growth of hyaline cartilage, for example in the coxofemoral joint on the acetabulum and/or femoral head.

KNEE

knee

STUDY DESIGN

Patients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic injury. They will be treated with autologous StroMed and Platelet Rich Plasma (PRP) as a direct injection to the affected joint. Patient outcomes will be tracked.

PATIENT INTAKE

Prior to scheduling the patient is screened by the doctor. All inclusion and exclusion criteria are considered and patient intake is done at this time. Images are evaluated. At this time, the entire procedure is reviewed with the patient.

AIM

The purpose of this study is to quantifiably determine if the proposed protocol, an intra-articular injection with a combination of StroMed and PRP, has a significant clinical effect on pain and inflammation associated with Osteoarthritis of the knee. Also, by obtaining MRIs at 0 and 6 months, we hope to see early evidence of re-growth of hyaline cartilage, for example on the femoral and tibial sides of the knee as well as posterior surface of the patella. Also the possibility of re-growth of meniscal tissue (fibro- cartilage).

SHOULDER

shoulder

STUDY DESIGN

Patients will be treated for Osteoarthritis (OA) of the shoulder due to degeneration or chronic injury. They will be treated with autologous StroMed and Platelet Rich Plasma (PRP) processed as a direct injection to the affected joint. Patient outcomes will be tracked.

PATIENT INTAKE

Prior to scheduling the patient is screened by the doctor. All inclusion and exclusion criteria are considered and patient intake is done at this time. Images are evaluated. At this time, the entire procedure is reviewed with the patient.

AIM

The purpose of this study is to quantifiably determine if the proposed protocol, an intra-articular injection with a combination of StroMed and PRP, has a significant clinical effect on pain and inflammation associated with Osteoarthritis of the shoulder. Also, by obtaining MRIs at 0 and 6 months, we hope to see early evidence of re-growth of hyaline cartilage, for example cartilage in the glenohumeral joint.

INCLUSION CRITERIA

CLINICAL TRIAL INCLUSION CRITERIA.

  • Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
  • Patients range from 18-90 years of age.
  • Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
  • Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
  • Patients with adequate cardiac and respiratory function.
  • Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT.
  • Patients must have adequate immune system function, with no known immunodeficiency disease.
  • Greater than 6 months shoulder, knee or hip pain with the index side (left or right).

For all current inclusions, Contact Us for more information.

EXCLUSION CRITERIA

CLINICAL TRIAL EXCLUSION CRITERIA.

  • Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
  • Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
  • Diagnosis of a transient ischemic attack in the 6 months prior to screening.
  • Patients infected with hepatitis B, C or HIV.
  • Patients with Body Mass Index (BMI) > 40kg/m2.
  • Presence of active infection.
  • Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
  • Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
    • Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis.
    • Corticosteroid injection at treatment site within 1 month.
    • Consistent use of NSAIDs within 48 hours of procedure.

For all current exclusions, Contact Us for more information.