Cell therapy made from a person's own cells for hip osteoarthritis pain
Tests a person's own cells with platelet rich plasma in adults with hip osteoarthritis.
Key facts
- Who runs it
- VivaTech International, Inc.
- Where
- Grove City, United StatesSee the site
- Trial code
- Registry title
- Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 4,000 people, planned
- Started
- Jul 2015
- Planned end
- Aug 2026
- Type of study
- Interventional
- Treatments tested
- [StroMed + platelet rich plasma (PRP)]
- Record updated
- 14 October 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with osteoarthritis of the hip and hip pain for more than 6 months. They get a cell therapy made from their own cells, plus platelet rich plasma.
- Age
- 18 to 90 years
- Sex
- All sexes
- Disease stage
- Hip osteoarthritis from wear or long-term injury, with more than 6 months of hip pain on one side.
- Earlier treatment
- No strong opioid drugs for other pain in the previous 4 weeks. No corticosteroid injection at the treated site within 1 month. No regular NSAID use within 48 hours of the procedure.
- Biomarker or test result
- Creatinine ≤ 1.5 mg/dl (133 µmol/L). PT(INR) < 1.5.
Main reasons for not taking part
- Cancer within 5 years, except skin basal cell or squamous cell cancer removed by surgery
- Serious acute or unstable heart or blood vessel disease or stroke, or a mini-stroke (TIA) in the past 6 months
- Hepatitis B, hepatitis C or HIV infection
- Body Mass Index (BMI) > 40kg/m2
- Active infection or a known weak immune system
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Patients with indication of Osteoarthritis. 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 hip pain with the index side (left or right)
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:; Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than hip 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 hip. Follow-up will consist of a larger sample including 4,000 patients.
The group in the trial
- StroMed + Platelet Rich plasma [PRP]Treatment being tested
Because no enzymes or drugs are added with this mechanical process, the resulting (StroMed) cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Additional treatments with Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product by direct injection to affected joints.
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 Hip
- Plain-language title
- Cell therapy made from a person's own cells for hip osteoarthritis painGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT02844764, who can take part
- Record updated
- 14 October 2025