Rotator Cuff Tear - Partial ThicknessNCT02918136
Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears
A study testing Adipose derived regenerative cells and Cortisone Injectable in people with Rotator Cuff Tear - Partial Thickness, run by InGeneron, Inc. at 2 sites in United States.
Trial summary
This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries. Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Rotator Cuff Tear - Partial Thickness
- What is being tested?
- Adipose derived regenerative cells and Cortisone Injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 13 Dec 2018
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 30-75 years of age.
- Clinical symptoms consistent with a rotator cuff lesion including but not limited to pain, muscle weakness, or active-limited range of motion (AROM).
- Subjects who have not responded to physical therapy treatments for at least six weeks.
- Subjects with > 70% passive range of motion (PROM).
- Diagnosed with >50% tear to supraspinatus muscle or < 5mm separation assessed by MRI.
- Diagnosed with a partial-thickness rotator cuff tear
- The ability of subjects to give appropriate consent or have an appropriate representative available.
Who cannot join
- Age <30 or > 75
- Insufficient amount of subcutaneous tissue to allow recovery of 50cc of lipoaspirate.
- History of systemic malignant neoplasms within last 5 years.
- History of local neoplasm within the last 6 months and any history of local neoplasm at site of administration.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
- Subjects who are known to be HIV positive
Show all 21Show fewer
- Patients who have received a corticosteroid injection in rotator cuff site within last 3 months
- Severe arthrosis of the glenohumeral or acromioclavicular joint
- Irreparable rotator cuff tear (including rotator cuff tear arthropathy)
- Fatty atrophy above Grade 2 in affected shoulder
- Previous shoulder surgeries in affected shoulder
- History of tobacco use within the last 3 months
- Any contraindications to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures
- Patients on an active regimen of chemotherapy
- Patients with a documented history of liver disease or an ALT value >400
- Allergy to sodium citrate of any "caine" type of local anesthetic
- Patients pregnant or breast feeding
- Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
- Uncooperative patients or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sanford Orthopedics and Sports Medicine - Fargo
Fargo, North Dakota, 58103
Sanford orthopedics and Sports Medicine - Sioux Falls
Sioux Falls, South Dakota, 57104
About this study
Official title: Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears
This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries.
Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury
Read the detailed description
The primary objectives of this study were to evaluate the safety of adult Adipose-Derived Stem Cell (ADRC) injection into partial thickness rotator cuff tears as indicated through adverse event rate and efficacy of pain and function through Rand short form-36 questionnaire and ASES Shoulder Score health questionnaires.
The secondary objective of this study was to assess the efficacy of adult ADRC injection into partial thickness rotator cuff tears through MRIs pre-and post-injection for the therapeutics intent to treat a rotator cuff injury.
Patients enrolled on this study received either ADRC (i.e., investigational treatment group) or TAU (i.e., control group). The investigational treatment group underwent a small liposuction procedure and received rotator cuff repair treatment with an ultrasound-guided injection of 5cc ADRCs into the point of injury. The control group received a 5cc cortisone injection. All patients, regardless of treatment, were followed up as indicated on the schedule of events table in the clinical study protocol.
Two clinical trial sites (Sioux Falls, SD and Fargo ND) enrolled subjects in this study.
- Conditions
- Rotator Cuff Tear - Partial Thickness
- Being tested
- Adipose derived regenerative cells, Cortisone Injectable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose derived regenerative cellsBiological
Also called ADRCs
Cortisone InjectableDrug
Also called steroid
| Study group | Role | What they receive |
|---|---|---|
| adipose-derived stem cell injection | Experimental | ultrasound guided injection of 5cc of adipose-derived stem cells (ADSCs) Receives: Biological: Adipose derived regenerative cells |
| cortisone injection | Active comparator | ultrasound guided injection of cortisone Receives: Drug: Cortisone Injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety evaluation as indicated by collection of adverse events
Measured: enrollment through 12months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion31 Jul 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tear - Partial ThicknessStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- InGeneron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Hurd, M.D., Principal investigator, Sanford Orthopedics & Sports Medicine - Sioux Falls, SD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918136
- Sponsor's protocol ID
- RTC-001
- Status last verified
- Feb 2021
- First submitted
- 26 Sep 2016
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hurd JL, Facile TR, Weiss J, Hayes M, Hayes M, Furia JP, Maffulli N, Winnier GE, Alt C, Schmitz C, Alt EU, Lundeen M. Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study. J Orthop Surg Res. 2020 Mar 30;15(1):122. doi: 10.1186/s13018-020-01631-8.
PubMed 32238172
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT02918136
- Acronym / sponsor ID
- RTC-001
- Conditions
- Rotator Cuff Tear - Partial Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- InGeneron, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 28 Sep 2016 (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.
This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries.
Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury
Detailed description
The primary objectives of this study were to evaluate the safety of adult Adipose-Derived Stem Cell (ADRC) injection into partial thickness rotator cuff tears as indicated through adverse event rate and efficacy of pain and function through Rand short form-36 questionnaire and ASES Shoulder Score health questionnaires.
The secondary objective of this study was to assess the efficacy of adult ADRC injection into partial thickness rotator cuff tears through MRIs pre-and post-injection for the therapeutics intent to treat a rotator cuff injury.
Patients enrolled on this study received either ADRC (i.e., investigational treatment group) or TAU (i.e., control group). The investigational treatment group underwent a small liposuction procedure and received rotator cuff repair treatment with an ultrasound-guided injection of 5cc ADRCs into the point of injury. The control group received a 5cc cortisone injection. All patients, regardless of treatment, were followed up as indicated on the schedule of events table in the clinical study protocol.
Two clinical trial sites (Sioux Falls, SD and Fargo ND) enrolled subjects in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adipose-derived stem cell injection | Experimental | Biological: Adipose derived regenerative cellsultrasound guided injection of 5cc of adipose-derived stem cells (ADSCs) |
| cortisone injection | Active comparator | Drug: Cortisone Injectableultrasound guided injection of cortisone |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females 30-75 years of age.
- Clinical symptoms consistent with a rotator cuff lesion including but not limited to pain, muscle weakness, or active-limited range of motion (AROM).
- Subjects who have not responded to physical therapy treatments for at least six weeks.
- Subjects with > 70% passive range of motion (PROM).
- Diagnosed with >50% tear to supraspinatus muscle or < 5mm separation assessed by MRI.
Key exclusion criteria (21 listed)
- Age <30 or > 75
- Insufficient amount of subcutaneous tissue to allow recovery of 50cc of lipoaspirate.
- History of systemic malignant neoplasms within last 5 years.
- History of local neoplasm within the last 6 months and any history of local neoplasm at site of administration.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
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 |
|---|---|---|
| Adipose derived regenerative cellsAlso: ADRCs | Biological | adipose-derived stem cell injection |
| Cortisone InjectableAlso: steroid | Drug | cortisone injection |
Primary outcome
safety evaluation as indicated by collection of adverse events
Time frame: enrollment through 12months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 32238172Hurd JL, Facile TR, Weiss J, Hayes M, Hayes M, Furia JP, Maffulli N, Winnier GE, Alt C, Schmitz C, Alt EU, Lundeen M. Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study. J Orthop Surg Res. 2020 Mar 30;15(1):122. doi: 10.1186/s13018-020-01631-8.
- Individual participant dataSharing planned: No
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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.
Jason Hurd, M.D. principal investigator
Sanford Orthopedics & Sports Medicine - Sioux Falls, SD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose derived regenerative cells and Cortisone Injectable in people with Rotator Cuff Tear - Partial Thickness, run by InGeneron, Inc. 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 11 Feb 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety evaluation as indicated by collection of adverse events (time frame: enrollment through 12months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918136, which also lists 1 linked publication.
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 11 Feb 2021.