Safety and Feasibility of ADRCs (Adipose Derived Regenerative Cells) in Patients With Grade II Hamstring Tears

Study Overview
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Brief Summary
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To evaluate the safety and feasibility of adipose-derived regenerative cells injected into tears of the hamstring muscle.

Detailed Description
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The RECOVER Clinical Trial is a prospective, randomized, multi-center device trial intended to assess safety and feasibility, and inform dose selection in preparation for a pivotal trial. Subjects that have Grade II tears of the hamstring will be evaluated for eligibility in this study. 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.

Official Title
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Double-blind, Placebo Controlled, Multi-center Safety and Feasibility Study in Patients With Documented Grade II Hamstring Tears Treated With Intramuscularly Delivered Adipose Derived Regenerative Cells - RECOVER

Conditions
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Muscle Tear

Intervention / Treatment
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* Device: ADRCs prepared by investigational Celution Device
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade II tears (≥5%) of the hamstring Weakness or inability to use affected muscle Ability to safely undergo liposuction Exclusion Criteria: Tears restricted to the ligament (i.e. no muscle tear) 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose ADRC<br>ADRCs prepared by investigational Celution Device | Device: ADRCs prepared by investigational Celution Device<br>* 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<br>|
| Experimental: High Dose ADRC<br>ADRCs prepared by investigational Celution Device | Device: ADRCs prepared by investigational Celution Device<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo<br>* Placebo is visually matched solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE and SAE Monitoring | AE and SAE Monitoring | Follow up period (Up to 24 Months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength | Assessed by strength testing | Follow up to Completion ((Up to 24 Months) | 
| Change in pain and function | Assessed by patient reported outcomes | Baseline to Completion (Up to 24 months) | 
| Change in lesion size | Change from baseline in lesion size | Baseline to Completion (Up to 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat, Hamstring, Tear, Muscle, Grade, adipose, cells, regenerative, Celution, stem, cell, liposuction