Muscle TearPhase 1/2RECOVERNCT02045888
Safety and Feasibility of ADRCs (Adipose Derived Regenerative Cells) in Patients With Grade II Hamstring Tears
A Phase 1/2 study testing ADRCs prepared by investigational Celution Device in people with Muscle Tear, run by Cytori Therapeutics at 2 sites in United States.
Trial summary
To evaluate the safety and feasibility of adipose-derived regenerative cells injected into tears of the hamstring muscle. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Muscle Tear
- What is being tested?
- ADRCs prepared by investigational Celution Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Nov 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Grade II tears (≥5%) of the hamstring
- Weakness or inability to use affected muscle
- Ability to safely undergo liposuction
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90045
About this study
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
To evaluate the safety and feasibility of adipose-derived regenerative cells injected into tears of the hamstring muscle.
Read the 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.
- Conditions
- Muscle Tear
- Being tested
- ADRCs prepared by investigational Celution Device, Placebo
- Keywords
- Hamstring, Tear, Muscle, Grade, adipose, cells, regenerative, Celution, stem, cell, liposuction, fat
- Medical subject headings
- Lacerations, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRCs prepared by investigational Celution DeviceDevice
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
PlaceboBiological
Placebo is visually matched solution
| Study group | Role | What they receive |
|---|---|---|
| Low Dose ADRC | Experimental | ADRCs prepared by investigational Celution Device Receives: Device: ADRCs prepared by investigational Celution Device |
| High Dose ADRC | Experimental | ADRCs prepared by investigational Celution Device Receives: Device: ADRCs prepared by investigational Celution Device |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and SAE Monitoring
AE and SAE Monitoring
Measured: Follow up period (Up to 24 Months)
Secondary outcomes (3)
Change in muscle strength
Assessed by strength testing
Measured: Follow up to Completion ((Up to 24 Months)
Change in pain and function
Assessed by patient reported outcomes
Measured: Baseline to Completion (Up to 24 months)
Change in lesion size
Change from baseline in lesion size
Measured: Baseline to Completion (Up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Withdrawn (No Participants Enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, MD, Study chair, Cytori Therapeutics, Inc.,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045888
- Sponsor's protocol ID
- RECOVER
- Acronym
- RECOVER
- Status last verified
- Nov 2014
- First submitted
- 13 Jan 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02045888
- Acronym / sponsor ID
- RECOVER / RECOVER
- Conditions
- Muscle Tear
- Keywords
- Hamstring, Tear, Muscle, Grade, adipose, cells, regenerative, Celution
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn (No Participants Enrolled)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and feasibility of adipose-derived regenerative cells injected into tears of the hamstring muscle.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose ADRC | Experimental | Device: ADRCs prepared by investigational Celution DeviceADRCs prepared by investigational Celution Device |
| High Dose ADRC | Experimental | Device: ADRCs prepared by investigational Celution DeviceADRCs prepared by investigational Celution Device |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Grade II tears (≥5%) of the hamstring
- Weakness or inability to use affected muscle
- Ability to safely undergo liposuction
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADRCs prepared by investigational Celution DeviceADRCs (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 | Device | High Dose ADRC, Low Dose ADRC |
| PlaceboPlacebo is visually matched solution | Biological | Placebo |
Primary outcome
AE and SAE Monitoring
Time frame: Follow up period (Up to 24 Months)
AE and SAE Monitoring
3 secondary outcomes
Change in muscle strength
Time frame: Follow up to Completion ((Up to 24 Months)
Change in pain and function
Time frame: Baseline to Completion (Up to 24 months)
Change in lesion size
Time frame: Baseline to Completion (Up to 24 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
Related trials for Muscle Tear
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Recruiting
Thermal Therapies in the Treatment of Muscle Injuries
Hamstring Injuries, Hamstring Muscle Repair
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingObservational study
Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
Rotator Cuff Injuries, Rotator Cuff Tear
Active, not recruitingObservational study
Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair
Rotator Cuff Tears, Tendon Thickening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Kesten, MD study chair
Cytori Therapeutics, Inc.,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADRCs prepared by investigational Celution Device in people with Muscle Tear, run by Cytori Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE and SAE Monitoring (time frame: Follow up period (Up to 24 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.