Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis

NCT03269409 | Terminated Phase 1 FDA Device

• 1 other identifier: 16-003846
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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 in one hip and hip decompression supplemented with adipose derived regenerative cells in patients with osteonecrosis in both of their hips.

Conditions

Osteonecrosis

Outcome Measures

Primary Outcomes (1)

• Safety, as measured by the type and number of serious adverse events related to Hip Decompression supplemented with autologous ADRC transplantation compared to Hip Decompression alone.

  Serious adverse events will only include those that are determined to be related to the transplantation of ADRC and/or Hip Decompression.

  End of the study (24 months)

Secondary Outcomes (2)

• In vitro laboratory metrics as measured by flow analysis as well as proliferation and differentiation potential of adipose and bone marrow derived mesenchymal stem cells (MSCs).

  Preoperative, Month 12, and Month 24

• Initial signals of efficacy as measured by MRI lesion volume quantification and patient reported outcome metrics.

  Preoperative, Month 12, and Month 24

Study Arms (2)

Hip Decompression with lactated ringers

SHAM COMPARATOR

Subjects will receive standard of care hip decompression along with an injection of approximately 5 mls. of lactated ringers.

Other: Lactated Ringers

Hip Decompression with ADRC

EXPERIMENTAL

Subjects in this arm will have Adipose Derived Regenerative Cells (ADRC)harvested through autologous liposuction and processed outside the body using The Celution 800/GP System (Cytori Therapeutics) before having approximately 5 mls. of ADRCs transplanted into the femoral head after standard of care hip decompression.

Device: The Celution 800/GP System (Cytori Therapeutics); Biological: Adipose Derived Regenerative Cells (ADRC)

Interventions

Lactated Ringers OTHER

Approximately 5 mls of lactated ringers will be injected after decompression into the hip that does not receive adipose derived regenerative cells.

Hip Decompression with lactated ringers

The Celution 800/GP System (Cytori Therapeutics) DEVICE

The Celution 800/GP System will be used for the preparation of adipose derived regenerative cells from lipoaspirate. The adipose derived regenerative cells will then be transplanted into the hip, post decompression.

Hip Decompression with ADRC

Adipose Derived Regenerative Cells (ADRC) BIOLOGICAL

Subjects in this arm will have Adipose Derived Regenerative Cells (ADRC)harvested through autologous liposuction and processed outside the body using The Celution 800/GP System (Cytori Therapeutics) before having approximately 5 mls. of ADRCs transplanted into the femoral head after standard of care hip decompression.

Hip Decompression with ADRC

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 22-70 years of age.
• No articular surface collapse of the femoral heads 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 360 mL). A plastic surgeon evaluation will be performed in order to determine adequate adipose tissue is available for harvest.
• Capacity to provide informed consent
• Ability to comply with protocol
• Normal laboratory values of CBC, CRP, AST, ALT, Bilirubin (total \& direct), BUN and Creatinine.

You may not qualify if:

• Post traumatic femoral head osteonecrosis.
• Osteonecrosis of the femoral head in 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 PTT \>13.8 seconds, 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.
• Patients who have aPTT values greater than or equal to 1.8 times the normal limit.
• Patients who are actively or recently received glycoprotein IIb/IIIa inhibitors (abciximab/ ReoPro, Aggrastat/ tirofiban, eptifibatide/ Integrilin)
• All patients who have inadequate fat deposits (i.e. \< 200 ml of lipoaspirate from 3 bilateral sites) will be excluded from the study.
• Lumbar radiculopathy, and/or neurogenic or vascular claudication.
• Active Skin infection at the time of surgery
• Active Local bone infection
• Patients in active treatment for cancer or a blood dyscrasia, or having received chemotherapy, radiotherapy or immunotherapy in past 1 year.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteonecrosis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rafael J Sierra, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics

Model Details: Cytori Celution 800/GP System to process ADRC from lipoaspirate at the point of care.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: November 15, 2017
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

US (1)