Rotator Cuff TearsNCT04077190
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
A study testing Adipose-derived stem cells and cortisone injection in people with Rotator Cuff Tears, run by InGeneron, Inc. at 2 sites in United States.
Trial summary
Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Adipose-derived stem cells and cortisone injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2019to 1 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient completed participation in RC-001 (NCT02918136) study
- Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial.
Who cannot join
- none
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: Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.
Read the detailed description
The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.
The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the initiation of a pivotal study to study the same.
- Conditions
- Rotator Cuff Tears
- Being tested
- Adipose-derived stem cells, cortisone injection
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived stem cellsDevice
5cc adipose derived stem cells.
cortisone injectionDevice
cortisone injection
| Study group | Role | What they receive |
|---|---|---|
| adipose-derived stem cell injection | Experimental | Ultrasound guided injection of 5cc adipose derived stem cells Receives: Device: Adipose-derived stem cells |
| cortisone injection | Active comparator | Ultrasound guided injection of cortisone Receives: Device: cortisone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Adverse event rate
Measured: at 24 months
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Adverse event rate
Measured: at 36 months
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Short form-36 score compared to baseline (total score = 800)
Measured: at 24 months
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Short form-36 score compared to baseline (total score = 800)
Measured: at 36 months
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
ASES score compared to baseline (total score = 100)
Measured: at 24 months
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
ASES score compared to baseline (total score = 100)
Measured: at 36 months
Secondary outcomes (1)
Long term efficacy will be evaluated through MRIs pre- and post-injection for the therapeutic intent to treat a rotator cuff injury: Percentage improvement in tendon tear size and thickness
Percentage improvement in tendon tear size and thickness
Measured: at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Aug 2019
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- InGeneron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jason Hurd, MD, Principal investigator, Sanford Orthopedics & Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077190
- Sponsor's protocol ID
- RC-003
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT04077190
- Acronym / sponsor ID
- RC-003
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- InGeneron, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 4 Sep 2019 (actual)
- 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.
Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.
Detailed description
The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.
The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the initiation of a pivotal study to study the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adipose-derived stem cell injection | Experimental | Device: Adipose-derived stem cellsUltrasound guided injection of 5cc adipose derived stem cells |
| cortisone injection | Active comparator | Device: cortisone injectionUltrasound guided injection of cortisone |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient completed participation in RC-001 (NCT02918136) study
- Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial.
Key exclusion criteria (1 listed)
- none
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 stem cells5cc adipose derived stem cells. | Device | adipose-derived stem cell injection |
| cortisone injectioncortisone injection | Device | cortisone injection |
Primary outcome
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Time frame: at 24 months
Adverse event rate
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Time frame: at 36 months
Adverse event rate
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Time frame: at 24 months
Short form-36 score compared to baseline (total score = 800)
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Time frame: at 36 months
Short form-36 score compared to baseline (total score = 800)
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
Time frame: at 24 months
ASES score compared to baseline (total score = 100)
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
Time frame: at 36 months
ASES score compared to baseline (total score = 100)
1 secondary outcome
Long term efficacy will be evaluated through MRIs pre- and post-injection for the therapeutic intent to treat a rotator cuff injury: Percentage improvement in tendon tear size and thickness
Time frame: at 36 months
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 3 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tears
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
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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, MD principal investigator
Sanford Orthopedics & Sports Medicine
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 stem cells and cortisone injection in people with Rotator Cuff Tears, 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 2 inclusion and 1 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 3 Aug 2022. 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?
Long term Safety as indicated through adverse event rate between ADSC and TAU arms (time frame: at 24 months). The study lists 6 primary outcomes in all. 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 3 Aug 2022.