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 people with osteoarthritis in their knee. Participants will receive a type of cell therapy to help with pain and inflammation related to their condition.
Are You a Good Fit for This Trial?
Must not be takingStrong opioidsCorticosteroid injectionsNSAIDs
Rules you outActive infectionPsychiatric disorderSubstance dependence
You may be able to join if
I have been diagnosed with osteoarthritis, grade 2 or more.
I am between 18 and 90 years old.
I am willing to follow treatment plans and have regular check-ins.
I have normal kidney function.
I have regular heart and lung function.
I have normal blood coagulation activity.
I do not have an immune system disease.
I have had knee 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 certain skin cancers.
I have serious heart or stroke issues.
I had a transient ischemic attack in the last 6 months.
I am infected with hepatitis B, C, or HIV.
My BMI is over 40.
I have an active infection.
I have a psychiatric disorder or substance dependence.
I have knee instability or significant knee deformities.
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 knee. Follow-up will consist of a larger sample including 4,000 patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients with indication of Osteoarthritis, grade 2 or more. 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 rena…
Inclusion Criteria:
1. Patients with indication of Osteoarthritis, grade 2 or more. 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 knee pain on the index side (left or right knee).
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:
1. Knee instability.
2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.
3. Gout or pseudo gout
4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis
5. Corticosteroid injection at treatment site within 1 month
6. Consistent use of NSAIDs within 48 hours of procedure.
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