Back to resultsEfficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid
Primary Purpose
Knee Osteoarthritis
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ascent
Standard
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
Sites / Locations
- Emory Sports Medicine Complex
- Emory At Dunwoody
- Emory Orthopaedics and Spine Center
- Emory at Smyrna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ascent Intervention Treatment
Standard Treatment
Arm Description
Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection
Standard treatment arm will receive a standard Corticosteroid injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03710005
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Suspended
Why Stopped
Suspended
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StimLabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ascent Intervention Treatment
Arm Type
Experimental
Arm Description
Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
Standard treatment arm will receive a standard Corticosteroid injection
Intervention Type
Procedure
Intervention Name(s)
Ascent
Intervention Description
Dehydrated Cell and Protein Concentrate injection
Intervention Type
Procedure
Intervention Name(s)
Standard
Intervention Description
Standard corticosteroid injection
Primary Outcome Measure Information:
Title
Measuring changes in quality of life due to treatment, as assessed by patient reported survey.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measured change in pain: VAS
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oluseun Olufade, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Sports Medicine Complex
City
Brookhaven
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Emory At Dunwoody
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Emory Orthopaedics and Spine Center
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
Emory at Smyrna
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35586982
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.
Results Reference
derived
Learn more about this trial
Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid
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