Safety and Feasibility of ADRCs (Adipose Derived Regenerative Cells) in Patients With Grade II Hamstring Tears
NCT ID: NCT02045888
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2014-01-31
2014-11-30
Brief Summary
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Detailed Description
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Part A of the trial will be an open-label, safety, feasibility and dose-escalation study to assess whether the treatment approach (liposuction, cell processing and injection) is feasible in athletic patients at one or both doses of ADRCs.
Part B of the trial is contingent on successful completion of Part A and is a multicenter, randomized, double blind trial of both doses of ADRCs vs. placebo.
In both parts of the study, following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo liposuction under general or local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate intramuscular administration under ultrasound guidance.
The first 5 patients of Part A will receive 0.2 million cells/kg body weight (maximum of 20 million cells) while the second 5 patients will receive 0.4 million cells/kg body weight (maximum of 40 million cells).
If the study is shown to be safe and feasible in Part A then patients in Part B of the study will be randomly assigned to receive one of two doses of ADRCs or a visually-matched placebo in a 1:1:1 ratio. If they receive the placebo they will undergo a liposuction and sham intramuscular injection procedure in which they will receive placebo.Part B will receive placebo, 0.2 million cells/kg body weight (maximum of 20 million cells), or 0.4 million cells/kg body weight (maximum of 40 million cells).
Patients in Part A of the study will be followed through to 90 days post-procedure. Patients in Part B of the study will be followed through to 24 months post-procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose ADRC
ADRCs prepared by investigational Celution Device
ADRCs prepared by investigational Celution Device
ADRCs (low dose and high dose) to be used in investigational treatment will be prepared using the investigational Celution Device which is being investigated under IDE 15363
High Dose ADRC
ADRCs prepared by investigational Celution Device
ADRCs prepared by investigational Celution Device
ADRCs (low dose and high dose) to be used in investigational treatment will be prepared using the investigational Celution Device which is being investigated under IDE 15363
Placebo
Placebo
Placebo
Placebo is visually matched solution
Interventions
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ADRCs prepared by investigational Celution Device
ADRCs (low dose and high dose) to be used in investigational treatment will be prepared using the investigational Celution Device which is being investigated under IDE 15363
Placebo
Placebo is visually matched solution
Eligibility Criteria
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Inclusion Criteria
* Weakness or inability to use affected muscle
* Ability to safely undergo liposuction
Exclusion Criteria
* Known spine or disc disease or sciatic nerve disease
* Known neuromuscular disease
* Pregnant or lactating status
* Any condition requiring immunosuppressive medication or use of systemic steroids
* Known history of HIV, or has active Hepatitis B or active Hepatitis C
* Cancer requiring chemotherapy or resection within the last 5 years (other than basal cell carcinoma)
20 Years
60 Years
ALL
No
Sponsors
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Cytori Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Kesten, MD
Role: STUDY_CHAIR
Cytori Therapeutics, Inc.,
Locations
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Los Angeles, California, United States
Houston, Texas, United States
Countries
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Other Identifiers
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RECOVER
Identifier Type: -
Identifier Source: org_study_id