Could your own cells fix your shoulder arthritis?
NCT ID NCT02844738
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a treatment made from a patient's own cells (StroMed) and platelet-rich plasma can reduce pain and inflammation from shoulder osteoarthritis. The first 50 participants will receive injections, and then up to 4,000 more will join to confirm safety and effectiveness. Researchers will track changes in shoulder function, pain, and even look for cartilage regrowth on MRI scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- StroMed (a patient's own regenerative cells) plus platelet-rich plasma (PRP)
- What this could lead to
- If it works, this could offer a new way to reduce pain and improve shoulder function without surgery or long-term medication.
- What could go wrong
- This is an early Phase 2 study with no placebo group, so results may be due to chance. The larger follow-up may not confirm benefits, and risks like infection or injection-site reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 4,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2015
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 shoulder pain with the index side (left or right shoulder). 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, 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. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis 2. Corticosteroid injection at treatment site within 1 month 3. Consistent use of NSAIDs within 48 hours of procedure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VivaTech International, Inc.
RECRUITINGGrove City, Pennsylvania, 16127, United States
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