Taking people in United StatesPhase 2
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
Key facts
- Who runs it
- VivaTech International, Inc.
- Where
- Grove City, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 4,000 people, planned
- Started
- Jul 2015
- Planned end
- Aug 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- [StroMed + platelet rich plasma (PRP)]
- [PRP] platelet rich plasma
- Record updated
- 14 October 2025
Who can take part
- Age
- 18 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury
- Patients range from 18-90 years of age
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews
- Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl
- Patients with adequate cardiac and respiratory function
- Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT
- Patients must have adequate immune system function, with no known immunodeficiency disease
- Greater than 6 months knee pain on the index side (left or right knee)
Who cannot take part
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Diagnosis of a transient ischemic attack in the 6 months prior to screening
- Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:; Knee instability; A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery; Gout or pseudo gout; Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis; Corticosteroid injection at treatment site within 1 month; Consistent use of NSAIDs within 48 hours of procedure
- Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
- Patients infected with hepatitis B, C or HIV
- Presence of active infection
- Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
- Patients with Body Mass Index (BMI) > 40kg/m2
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in United States
- VivaTech International, Inc.Grove City, United StatesContact: Scott M Herkes, MBATaking people
About the trial
What the trial wants to find out
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.
The 2 groups in the trial
- Cohort 1Treatment being tested
Interventions assigned by Principal Investigator
Treatment: [StroMed + platelet rich plasma (PRP)] and [PRP] platelet rich plasma
- Cohort 2Treatment being tested
Interventions assigned by Principal Investigator
Treatment: [StroMed + platelet rich plasma (PRP)] and [PRP] platelet rich plasma
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee
- Fit questions
- Built from NCT02844751, who can take part
- Record updated
- 14 October 2025