Clinical trial NCT03710005: Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid
Official title: Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) ("Ascent") Versus Corticosteroid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: StimLabs
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Measuring changes in quality of life due to treatment, as assessed by patient reported survey.
timeFrame: 12 months
Secondary outcomes:
measure: Measured change in pain: VAS
timeFrame: 12 months
Other outcomes:
Locations:
city: Brookhaven
country: United States
facility: Emory Sports Medicine Complex
state: Georgia
city: Dunwoody
country: United States
facility: Emory At Dunwoody
state: Georgia
city: Johns Creek
country: United States
facility: Emory Orthopaedics and Spine Center
state: Georgia
city: Smyrna
country: United States
facility: Emory at Smyrna
state: Georgia
Study officials:
affiliation: Emory University
name: Oluseun Olufade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.