Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/4/2018 |
| Start Date: | November 15, 2017 |
| End Date: | December 2018 |
| Contact: | Teron T Cox |
| Email: | cox.teron@mayo.edu |
| Phone: | 507-293-9466 |
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
This randomized clinical trial aims to determine if cells from a patient's own adipose tissue
is safe and capable of helping regenerate the femoral head in patients with osteonecrosis.
The standard of care is known as hip decompression which simply removes dead tissue from the
femoral head and creates a new cavity to be filled in by healthy bone. This trial will use
hip decompression plus saline injection in one hip and hip decompression supplemented with
adipose derived regenerative cells in patients with osteonecrosis in both of their hips.
is safe and capable of helping regenerate the femoral head in patients with osteonecrosis.
The standard of care is known as hip decompression which simply removes dead tissue from the
femoral head and creates a new cavity to be filled in by healthy bone. This trial will use
hip decompression plus saline injection in one hip and hip decompression supplemented with
adipose derived regenerative cells in patients with osteonecrosis in both of their hips.
Preclinical and clinical data suggest that ADRC may serve as a safe and efficacious adjuvant
agent for the treatment of ON. However, no randomized control study in the United States has
formally evaluated safety of ADRC in the setting of ON. Therefore, the primary endeavor of
this Phase I pilot study will be to evaluate safety of ADRC for pre-collapse ON of the
femoral head.
The Celution System (Cytori Therapeutics, San Diego, USA) for preparation of ADRC from
lipoaspirate is currently being evaluated in FDA approved clinical trials including an
orthopedic indication (osteoarthritis). In addition, the device has a registration in Europe
and Class I approval in Japan. As such, it serves as a known platform that produces a
clinical grade product for human use. Other devices on the market process lipoaspirate by
either mechanical, washing, or centrifugation methods; however, the remaining components of
original adipose tissue are significant and impair the regenerative process. Derivation of
relatively pure ADRC has been achieved by few devices and the Cytori Celution System is the
only one to our knowledge with a sufficient safety and efficacy track record enabling
multiple investigational device exemption (IDE) approvals. The reagent used (Celase®) is of a
clinical and pharmacologic grade for use in humans. The production of Celase is free of
mammalian products.
agent for the treatment of ON. However, no randomized control study in the United States has
formally evaluated safety of ADRC in the setting of ON. Therefore, the primary endeavor of
this Phase I pilot study will be to evaluate safety of ADRC for pre-collapse ON of the
femoral head.
The Celution System (Cytori Therapeutics, San Diego, USA) for preparation of ADRC from
lipoaspirate is currently being evaluated in FDA approved clinical trials including an
orthopedic indication (osteoarthritis). In addition, the device has a registration in Europe
and Class I approval in Japan. As such, it serves as a known platform that produces a
clinical grade product for human use. Other devices on the market process lipoaspirate by
either mechanical, washing, or centrifugation methods; however, the remaining components of
original adipose tissue are significant and impair the regenerative process. Derivation of
relatively pure ADRC has been achieved by few devices and the Cytori Celution System is the
only one to our knowledge with a sufficient safety and efficacy track record enabling
multiple investigational device exemption (IDE) approvals. The reagent used (Celase®) is of a
clinical and pharmacologic grade for use in humans. The production of Celase is free of
mammalian products.
Inclusion Criteria
- Males and females 18-70 years of age.
- Diagnosis of Steinberg Classification osteonecrosis (Stages < IIC) as measured by MRI.
- Target disease or condition: Bilateral pre-collapse osteonecrosis of the femoral head.
- Atraumatic osteonecrosis of the femoral head (all other etiologies eligible including
corticosteroid and alcohol induced osteonecrosis).
- Ability to safely undergo liposuction that will result in the harvest of a sufficient
quantity of adipose tissue (approximately 300 mL)
- Capacity to provide informed consent
- Ability to comply with protocol
- Normal laboratory values of complete blood count (CBC), C reactive protein (CRP),
aspartate aminotransferase (AST), alanine aminotransferase (ALT), Bilirubin, blood
urea nitrogen (BUN) and Creatinine. If any value is abnormal, then the patient must be
under active monitoring by appropriate subspecialist.
Exclusion Criteria:
- Post traumatic femoral head osteonecrosis.
- Osteonecrosis of the femoral head (stages ≥ IIIA) according to the Steinberg
classification.
- Asymptomatic osteonecrosis on exam
- Flattening of the femoral head (Steinberg classification Type IV) or articular
cartilage collapse at the time of core decompression surgery.
- Septic arthritis, stress fracture, or non-osteonecrosis metabolic bone diseases (e.g.,
Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism,
osteopetrosis, and fibrous dysplasia including monostotic, polyostotic, and
McCune-Albright syndrome.
- Skeletal immaturity.
- Known history of HIV, or has active Hepatitis B or active Hepatitis C.
- Disease or medication-related disorder of coagulation (i.e., elevated partial
thromboplastin time (PTT) >13.8 seconds, international normalized ratio (INR) >1.2, or
low platelet count <150x109/L). Patients on coumadin, heparin products, and novel oral
anticoagulants will be excluded. Antiplatelet medications (e.g. aspirin, clopidogrel)
are permitted as long as the aforementioned coagulation labs are within the specified
range.
- Fibromyalgia, lumbar radiculopathy, and/or neurogenic or vascular claudication.
- Skin infection or any abnormal skin pathology at the time of surgery.
- Local bone infection at the time of surgery.
- Patients in active treatment for cancer or a blood dyscrasia, or having received
chemotherapy, radiotherapy or immunotherapy in past 1 year.
- Participation in another clinical study in the past 30 days or concurrent
participation in another clinical trial.
- MRI-incompatible internal devices (pacemakers, aneurysm clips, etc).
- Patients with poorly controlled diabetes mellitus (HbA1C ≥ 8%), peripheral neuropathy,
or known concomitant vascular problems.
- Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis
or anti-angiogenesis treatment (e.g., anti-VEGF).
- Patients requiring bisphosphonate treatment after the procedure.
- Pregnant or lactating female patients.
- Prisoners.
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