Osteoarthritis study: PRP Concentrate Arm vs Sterile Normal Saline
Official title Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
ClinicalTrials.gov ID: NCT04238143
What this study is testing
What is PRP Concentrate Arm 1?
This is an investigational treatment being studied to help with osteoarthritis. It is designed to use your own blood cells and growth factors to support healing in the joint.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if this stem‑cell plus PRP treatment can relieve pain and slow joint damage in osteoarthritis patients.
- Who it's for
- Adults who have osteoarthritis in the knee, shoulder, hip, ankle/foot, or several joints.
- What's involved
- Participants receive an injection of their own stem cells mixed with platelet‑rich plasma. They will have baseline and follow‑up visits for assessments and monitoring.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon...
- No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures;
- Have the ability to understand and accept all items in Informed Consent Document;
- Have adequate perivascular and extracellular matrix donor tissues available;
- Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities
You likely can't join if
- Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking;
- Known active cancer, chemotherapy, or radiation therapy;
- Pregnancy;
- Active infections which would increase risk of patient to undergo treatment;
- High dose steroid users, or recipients of corticosteroids with a six month period before treatment date;
- Medication or Opiate addition, or in active treatment for drug rehabilitation;
See the full eligibility criteria
- Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis (PR);
- No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures;
- Have the ability to understand and accept all items in Informed Consent Document;
- Have adequate perivascular and extracellular matrix donor tissues available;
- Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities
- Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking;
- Known active cancer, chemotherapy, or radiation therapy;
- Pregnancy;
- Active infections which would increase risk of patient to undergo treatment;
- High dose steroid users, or recipients of corticosteroids with a six month period before treatment date;
- Medication or Opiate addition, or in active treatment for drug rehabilitation;
- History of documented severe traumatic brain injuries;
- In the opinion of the principal investigator/provider, the patient's condition or medical issues which would not allow the individual to fully accomplish or complete the study requirements
The study team makes the final eligibility decision.
Where it is enrolling
- Valencia, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Valencia, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.