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New treatment option for Osteoarthritis
Official title Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
ClinicalTrials.gov ID: NCT04238143
What this study is testing
What is PRP Concentrate Arm 1?
PRP Concentrate Arm 1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for osteoarthritis.
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
- Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures.
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's taking place
- Valencia, California, United States
- Stevensville, Montana, 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 - 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?
Study sites include Valencia, California, United States; Stevensville, Montana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.