Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid

• ClinicalTrials.gov Identifier: NCT03710005
• Recruitment Status: Suspended
• First Posted: October 17, 2018
• Last Update Posted: June 15, 2021
• Sponsor: StimLabs
• Information provided by (Responsible Party): StimLabs

Study Description

Brief Summary:

To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Procedure: Ascent; Procedure: Standard	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) ("Ascent") Versus Corticosteroid
• Actual Study Start Date: October 22, 2018
• Estimated Primary Completion Date: December 30, 2022
• Estimated Study Completion Date: January 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ascent Intervention Treatment; Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection	Procedure: Ascent; Dehydrated Cell and Protein Concentrate injection
Active Comparator: Standard Treatment; Standard treatment arm will receive a standard Corticosteroid injection	Procedure: Standard; Standard corticosteroid injection

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Measured change in pain: VAS [ Time Frame: 12 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Georgia

Emory Sports Medicine Complex

Brookhaven, Georgia, United States, 30329

Emory At Dunwoody

Dunwoody, Georgia, United States, 30338

Emory Orthopaedics and Spine Center

Johns Creek, Georgia, United States, 30097

Emory at Smyrna

Smyrna, Georgia, United States, 30080

Sponsors and Collaborators

StimLabs

Investigators

• Principal Investigator: Oluseun Olufade, MD; Emory University

More Information

• Responsible Party: StimLabs
• ClinicalTrials.gov Identifier: NCT03710005
• Other Study ID Numbers: SLAC-ORTHO-001
• First Posted: October 17, 2018
• Last Update Posted: June 15, 2021
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Dehydration; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes