No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
4,000 (estimated)
Sponsor
VivaTech International, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with hip osteoarthritis to see if a new type of cell therapy can help reduce pain and inflammation. Participants will receive treatment and need to complete follow-up evaluations over time.
Are You a Good Fit for This Trial?
Must not be takingStrong opioidsCorticosteroidsNSAIDs
You may be able to join if
I have been diagnosed with osteoarthritis.
I am between 18 and 90 years old.
I can follow the treatment plan and attend interviews.
I have a normal kidney function.
I have a normal heart and lung function.
I have a healthy immune system.
I have had hip pain for more than 6 months.
You may not be able to join if
I have had cancer in the last 5 years, except for some skin cancers.
I have serious heart or brain problems.
I have had a mini-stroke in the last 6 months.
I am infected with hepatitis B, hepatitis C, or HIV.
My Body Mass Index (BMI) is over 40.
I have an active infection.
I have a health issue or addiction that makes me unsuitable for the trial.
I have used strong painkillers recently for pain that is not from hip osteoarthritis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
1. Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
2. Patients range from 18-90 years of age.
3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
4. Patients with adequate renal function, Creat…
Inclusion Criteria:
1. Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
2. Patients range from 18-90 years of age.
3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
5. Patients with adequate cardiac and respiratory function.
6. Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT
7. Patients must have adequate immune system function, with no known immunodeficiency disease.
8. Greater than 6 months hip pain with the index side (left or right).
Exclusion Criteria:
1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
2. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
4. Patients infected with hepatitis B, C or HIV.
5. Patients with Body Mass Index (BMI) \> 40kg/m2
6. Presence of active infection.
7. 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.
8. 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.
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