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

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ClinicalTrials.gov Identifier: NCT02045888
Recruitment Status : Withdrawn (Withdrawn (No Participants Enrolled))
First Posted : January 27, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

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

Condition or disease Intervention/treatment Phase
Muscle Tear Device: ADRCs prepared by investigational Celution Device Biological: Placebo Phase 1 Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Low Dose ADRC
ADRCs prepared by investigational Celution Device
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

Experimental: High Dose ADRC
ADRCs prepared by investigational Celution Device
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 Comparator: Placebo
Placebo
Biological: Placebo
Placebo is visually matched solution




Primary Outcome Measures :
  1. AE and SAE Monitoring [ Time Frame: Follow up period (Up to 24 Months) ]
    AE and SAE Monitoring


Secondary Outcome Measures :
  1. Change in muscle strength [ Time Frame: Follow up to Completion ((Up to 24 Months) ]
    Assessed by strength testing

  2. Change in pain and function [ Time Frame: Baseline to Completion (Up to 24 months) ]
    Assessed by patient reported outcomes

  3. Change in lesion size [ Time Frame: Baseline to Completion (Up to 24 months) ]
    Change from baseline in lesion size



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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): NCT02045888


Locations
United States, California
Los Angeles, California, United States, 90045
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cytori Therapeutics
Investigators
Study Chair: Steven Kesten, MD Cytori Therapeutics, Inc.,

Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT02045888     History of Changes
Other Study ID Numbers: RECOVER
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Cytori Therapeutics:
Hamstring
Tear
Muscle
Grade
adipose
cells
regenerative
Celution
stem
cell
liposuction
fat