Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid

S

StimLabs

Status

Suspended

Conditions

Knee Osteoarthritis

Treatments

Procedure: Standard
Procedure: Ascent

Study type

Interventional

Funder types

Industry

Identifiers

NCT03710005
SLAC-ORTHO-001

Details and patient eligibility

About

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

Full 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

Enrollment

140 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

Ascent Intervention Treatment
Experimental group
Description:
Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection
Treatment:
Procedure: Ascent
Standard Treatment
Active Comparator group
Description:
Standard treatment arm will receive a standard Corticosteroid injection
Treatment:
Procedure: Standard

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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