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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Muscle Tear
• Intervention / Treatment: Device: ADRCs prepared by investigational Celution Device; Biological: Placebo

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
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
  • Texas
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo is visually matched solution
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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Cytori Therapeutics
• Investigators: Study Chair: Steven Kesten, MD, Cytori Therapeutics, Inc.,

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: cells; Muscle; fat; Hamstring; liposuction; Celution; adipose; regenerative; cell; stem; Tear; Grade
• Other Study ID Numbers: RECOVER