Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis
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|ClinicalTrials.gov Identifier: NCT03269409|
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteonecrosis||Other: Saline Device: The Celution System (Cytori Therapeutics) Biological: Adipose Derived Regenerative Cells (ADRC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
Sham Comparator: Hip Decompression with saline injection
Subjects will receive standard of care hip decompression along with an injection of 5 ccs of saline.
5 cc's of saline will be injected after decompression into the hip that does not receive adipose derived regenerative cells.
Experimental: Hip Decompression with ADRC
Subjects in this arm will have Adipose Derived Regenerative Cells (ADRC)harvested through autologous liposuction and processed outside the body using The Celution System (Cytori Therapeutics) before being transplanted into the femoral head after standard of care hip decompression.
Device: The Celution System (Cytori Therapeutics)
The Celution 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.
Biological: Adipose Derived Regenerative Cells (ADRC)
Adipose Derived Regenerative Cells (ADRC) will be harvested through autologous liposuction and processed outside the body autologous transplantation..
- Safety, as measured by the type of serious adverse events related to Hip Decompression supplemented with autologous ADRC transplantation compared to Hip Decompression alone. [ Time Frame: End of the study (24 months) ]Serious adverse events will only include those that are determined to be related to the transplantation of ADRC and/or Hip Decompression
- Safety, as measured by the number of serious adverse events related to Hip Decompression supplemented with autologous ADRC transplantation compared to Hip Decompression alone. [ Time Frame: End of the study (24 months) ]Serious adverse events will only include those that are determined to be related to the transplantation of ADRC and/or Hip Decompression
- Efficacy, as measured by change in MRI lesion volume. [ Time Frame: PreoperativeVisit, Month 12 ]Preoperative MRI and 1 year postoperative MRI will be compared based on formal quantification of the osteonecrotic lesion volume size.
- Efficacy, as change measured by patient reported outcome metrics via the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: Baseline, Month 24 ]
The HOOS is a 40 item self-report questionnaire with 5 subsets. The five subscales include 10 items on pain, 5 items for symptoms (3 symptoms items, 2 stiffness items) 17 items for activities for daily living (ADLs), 4 items for sports and recreations, and 4 items for hip related quality of life.
Scoring: Each question contains five answer choices ranging from never (score of 0) to extreme (score of 4). A normalized score is calculated for each subscale with 0 indicating extreme symptoms and 100 representing no symptoms.
- Efficacy, as change measured by patient reported outcome metrics via the 12 Question Short Form (SF-12) [ Time Frame: Baseline, Month 24 ]The SF-12 uses 12 questions to measure functional health and well-being from a patient's point of view. It measures eight concepts commonly represented in widely used surveys: physical functioning, role limitation due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health distress and psychological well-being). We will use the standard 4 week recall version.
- Efficacy, as change measured by patient reported outcome metrics via University of California Los Angeles (UCLA) Activity Score [ Time Frame: Baseline, Month 24 ]The UCLA Activity Score is a simple scale ranging from 1 to 10. The patient indicates their most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports".
- Efficacy, as change measured by patient reported outcome metrics via Harris Hip Score (HHS) [ Time Frame: Baseline, Month 24 ]The Harris Hip Score (HHS) has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes
- Sterility of ADRC samples as measured by gram stain and culture. [ Time Frame: Day of surgery ]Following cell processing in the Celution System, sterility testing will be performed using gram stain. A negative gram stain test result is required for ADRC samples prior to injection. If the gram stain is positive the regenerative product administration procedure must be stopped.
- Cell counts of the ADRC transplanted in the subject. [ Time Frame: Through study completion, approximately month 24 ]Cell products will be tested at the point-of-care for sterility. The remainder of the quality control sample will be returned to the laboratory for analysis of cell counts and functionality to work towards product standardization and monitoring.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269409
|Contact: Pam J Draayerfirstname.lastname@example.org|
|Contact: Teron T Coxemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Rafael J Sierra||Mayo Clinic|