Knee OsteoarthritisNCT03710005
Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid
A study testing Ascent and Standard in people with Knee Osteoarthritis, run by StimLabs at 4 sites in United States.
Trial summary
To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ascent and Standard
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Oct 2018to 31 May 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 20 years but less than 75 years old
- Both male and female (non-pregnant)
- Valid knee radiograph within 3 months of beginning treatment;
- Diagnosis of OA of the knee
- OA pain in the knee despite conservative measures
- Average daily VAS >= 3
- Off any NSAIDs for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection
- Kellgren-Lawrence system of Grade II, III, or IV
Who cannot join
- Kellgren-Lawrence Grade I
- Tense effusion of the knee
- Significant valgus/varus deformities
- Viscosupplementation within 6 months
- Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening
- Chronic opioid usage
Show all 14Show fewer
- History of Leukemia or Lymphoma
- History of any autoimmune disorders and disease
- Immunosuppressive medications
- Active, suspected, or prior infection to the joint
- Vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...)
- NSAIDs used within 1 week of the procedure
- History of bleeding disorders or inflammatory joint disease
- Patients who plan on becoming pregnant during study period
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Sports Medicine Complex
Brookhaven, Georgia, 30329
Emory At Dunwoody
Dunwoody, Georgia, 30338
Emory Orthopaedics and Spine Center
Johns Creek, Georgia, 30097
Emory at Smyrna
Smyrna, Georgia, 30080
About this study
Official title: Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) ("Ascent") Versus Corticosteroid
To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.
Read the detailed description
To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent
- Conditions
- Knee Osteoarthritis
- Being tested
- Ascent, Standard
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AscentProcedure or surgery
Dehydrated Cell and Protein Concentrate injection
StandardProcedure or surgery
Standard corticosteroid injection
| Study group | Role | What they receive |
|---|---|---|
| Ascent Intervention Treatment | Experimental | Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection Receives: Procedure: Ascent |
| Standard Treatment | Active comparator | Standard treatment arm will receive a standard Corticosteroid injection Receives: Procedure: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring changes in quality of life due to treatment, as assessed by patient reported survey.
The Quality of Life Survey is a patient-reported outcome measure divided into two parts. The first part of the Quality of Life questionnaire/survey will include 4 questions in which patients will be asked to evaluate their individual levels of knee problems (knee difficulty, knee confidence, and lifestyle modifications). Answers will be reported on a 5 point likert scale, in which higher scores indicate more severity, and lower scores indicate less severity. The second part of the questionnaire will include 6 categories (discomfort, mobility, self-care, anxiety, performance of activities, and sleeping). There will be 3 statements per category in which the patient is asked to indicate which statement best describes their current health. The questionnaire is scored by adding up the scores of each item to compute a total score.
Measured: 12 months
Secondary outcomes (1)
Measured change in pain: VAS
The Visual Analog scale is a patient-reported outcome measure. It will be presented numerically as an 11 point scale that will ask the patient to rate the severity of their pain on a scale form 0 to 10, which 10 being the most pain imaginable and 0 being the least (no pain). The numerical value will be reported based on the patient's response. The mean pain scores of each intervention group will be calculated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start22 Oct 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: FDA upregulation of dCPC.
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 Knee OsteoarthritisStudies 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
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- StimLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oluseun Olufade, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710005
- Sponsor's protocol ID
- SLAC-ORTHO-001
- Status last verified
- Jun 2024
- First submitted
- 12 Oct 2018
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olufade O, Negron G, Berrigan W, Sirutis B, Whitley J, Easley K, Chen Y, Mautner K. Amniotic dehydrated cell and protein concentrate versus corticosteroid in knee osteoarthritis: preliminary findings. Regen Med. 2022 Jul;17(7):431-443. doi: 10.2217/rme-2022-0005. Epub 2022 May 19.
PubMed 35586982
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) ("Ascent") Versus Corticosteroid
- ClinicalTrials.gov ID
- NCT03710005
- Acronym / sponsor ID
- SLAC-ORTHO-001
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA upregulation of dCPC.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- StimLabsIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 Oct 2018 (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.
To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.
Detailed description
To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascent Intervention Treatment | Experimental | Procedure: AscentInterventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection |
| Standard Treatment | Active comparator | Procedure: StandardStandard treatment arm will receive a standard Corticosteroid injection |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than 20 years but less than 75 years old
- Both male and female (non-pregnant)
- Valid knee radiograph within 3 months of beginning treatment;
- Diagnosis of OA of the knee
- OA pain in the knee despite conservative measures
Key exclusion criteria (14 listed)
- Kellgren-Lawrence Grade I
- Tense effusion of the knee
- Significant valgus/varus deformities
- Viscosupplementation within 6 months
- Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening
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 |
|---|---|---|
| AscentDehydrated Cell and Protein Concentrate injection | Procedure or surgery | Ascent Intervention Treatment |
| StandardStandard corticosteroid injection | Procedure or surgery | Standard Treatment |
Primary outcome
Measuring changes in quality of life due to treatment, as assessed by patient reported survey.
Time frame: 12 months
The Quality of Life Survey is a patient-reported outcome measure divided into two parts. The first part of the Quality of Life questionnaire/survey will include 4 questions in which patients will be asked to evaluate their individual levels of knee problems (knee difficulty, knee confidence, and lifestyle modifications). Answers will be reported on a 5 point likert scale, in which higher scores indicate more severity, and lower scores indicate less severity. The second part of the questionnaire will include 6 categories (discomfort, mobility, self-care, anxiety, performance of activities, and sleeping). There will be 3 statements per category in which the patient is asked to indicate which statement best describes their current health. The questionnaire is scored by adding up the scores of each item to compute a total score.
1 secondary outcome
Measured change in pain: VAS
Time frame: 12 months
Results and safety
The study was stopped early (reason given: FDA upregulation of dCPC.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 35586982Olufade O, Negron G, Berrigan W, Sirutis B, Whitley J, Easley K, Chen Y, Mautner K. Amniotic dehydrated cell and protein concentrate versus corticosteroid in knee osteoarthritis: preliminary findings. Regen Med. 2022 Jul;17(7):431-443. doi: 10.2217/rme-2022-0005. Epub 2022 May 19.
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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.
Oluseun Olufade, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascent and Standard in people with Knee Osteoarthritis, run by StimLabs at 4 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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: FDA upregulation of dCPC.). Results are not available in the source record.
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?
Measuring changes in quality of life due to treatment, as assessed by patient reported survey. (time frame: 12 months). 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 NCT03710005, 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 1 Jul 2024.