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

Muscle Tear Clinical Trial

— RECOVER  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02045888
• Other study ID #: RECOVER
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: January 13, 2014
• Last updated: November 19, 2014
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Tear

Intervention

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

Biological:
• Placebo
Placebo is visually matched solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE and SAE Monitoring	AE and SAE Monitoring	Follow up period (Up to 24 Months)	Yes
Secondary	Change in muscle strength	Assessed by strength testing	Follow up to Completion ((Up to 24 Months)	No
Secondary	Change in pain and function	Assessed by patient reported outcomes	Baseline to Completion (Up to 24 months)	No
Secondary	Change in lesion size	Change from baseline in lesion size	Baseline to Completion (Up to 24 months)	No