Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid
NCT ID: NCT03710005
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
51 participants
INTERVENTIONAL
2018-10-22
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ascent Intervention Treatment
Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection
Ascent
Dehydrated Cell and Protein Concentrate injection
Standard Treatment
Standard treatment arm will receive a standard Corticosteroid injection
Standard
Standard corticosteroid injection
Interventions
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Ascent
Dehydrated Cell and Protein Concentrate injection
Standard
Standard corticosteroid injection
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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StimLabs
INDUSTRY
Responsible Party
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Principal Investigators
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Oluseun Olufade, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory Sports Medicine Complex
Brookhaven, Georgia, United States
Emory At Dunwoody
Dunwoody, Georgia, United States
Emory Orthopaedics and Spine Center
Johns Creek, Georgia, United States
Emory at Smyrna
Smyrna, Georgia, United States
Countries
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References
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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.
Other Identifiers
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SLAC-ORTHO-001
Identifier Type: -
Identifier Source: org_study_id
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