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Femoral Head Osteonecrosis - Healing Genes
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Femoral Head Osteonecrosis

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Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis

Double Blind, Phase I, Randomized, Parallel Group Study of Hip Decompression Compared to Hip Decompression Supplemented at the Point of Care With Adipose Derived Regenerative Cells for Bilateral Pre-Collapse Femoral Head Osteonecrosis


Phase 1

DESCRIPTION:

The Mayo Clinic in MN is recruiting patients with bilateral femoral head osteonecrosis to trial a regenerative cell therapy made from the patient’s own adipose(fat tissue)-derived regenerative cells (ADRCs) as a treatment in combination with and compared to the standard therapy, saline injection.

Treatment requires lipoaspirate using the Celution System to draw and process the ADRCs before the hip decompression (a simple outpatient procedure) where one femoral head will received saline and the opposite will receive the ADRCs. Follow up will continue with physical assessments and questionnaires for ~24 months.


PATIENT MUST:

  • Be 18 to 70 years of age
  • Have a diagnosis of Steinberg Classification osteonecrosis (Stages < IIC) as measured by MRI, with bilateral pre-collapse osteonecrosis of the femoral head
  • Have no known history of HIV, or has active Hepatitis B or active Hepatitis C

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Lipoaspirate using the Celution System to draw and process the ADRCs.
  3. Hip decompression surgery with one femoral head treated with ADRCs and the opposite with saline injection.
  4. Follow up will continue with physical assessments and questionnaires for ~24 months.

LOCATIONS AND CONTACTS:

Trials will take place at the Mayo Clinic in Rochester in Rochester, MN, Map.

 

Contact: Teron T Cox  |  507-293-9466  |  [email protected]

Contact: Jennifer E Stortz, RN  |  507-293-9359  |  [email protected]

 

SPONSOR INFORMATION:

Mayo Clinic

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03269409

 

 

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