Study Stopped
Withdrawn (No Participants Enrolled)
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
1 other identifier
interventional
N/A
1 country
2
Brief Summary
To evaluate the safety and feasibility of adipose-derived regenerative cells injected into tears of the hamstring muscle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 13, 2014
CompletedFirst Posted
Study publicly available on registry
January 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 21, 2014
November 1, 2014
10 months
January 13, 2014
November 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AE and SAE Monitoring
AE and SAE Monitoring
Follow up period (Up to 24 Months)
Secondary Outcomes (3)
Change in muscle strength
Follow up to Completion ((Up to 24 Months)
Change in pain and function
Baseline to Completion (Up to 24 months)
Change in lesion size
Baseline to Completion (Up to 24 months)
Study Arms (3)
Low Dose ADRC
EXPERIMENTALADRCs prepared by investigational Celution Device
High Dose ADRC
EXPERIMENTALADRCs prepared by investigational Celution Device
Placebo
PLACEBO COMPARATORPlacebo
Interventions
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
Eligibility Criteria
You may qualify if:
- Grade II tears (≥5%) of the hamstring
- Weakness or inability to use affected muscle
- Ability to safely undergo liposuction
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Los Angeles, California, 90045, United States
Unknown Facility
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steven Kesten, MD
Cytori Therapeutics, Inc.,
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2014
First Posted
January 27, 2014
Study Start
January 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 21, 2014
Record last verified: 2014-11