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New treatment option for Osteoarthritis
Official title Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
ClinicalTrials.gov ID: NCT05507099
What this study is testing
What is Bone Marrow Aspirate, Lipoaspirate Concentrate?
Bone Marrow Aspirate, Lipoaspirate Concentrate is an investigational medicine, given as an injectable medicine, 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
- The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.
- Phase 2: a mid-size study of how well it works
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 95
You may be able to join if
- Male or female, aged 18 to 95 years old
- Residents of Canada
- Written informed consent to participate in the study
- Willingness and ability to comply with the study procedures and phone visit schedules and ability to follow verbal and written instruction
- The NRS for at least 5 daily measures will be used to calculate the average score. An average NRS pain score 4-9 (moderate to severe pain).
You likely can't join if
- Women who are pregnant or planning to become pregnant during the trial period.
- Women of childbearing potential (not surgically sterile or post-menopausal for at least one year) not using a highly effective method of...
- History of malignancy except for the diagnosis of basal cell carcinoma, within 5 years prior to pre-screening.
- Presence of retained rods or screws or insertion or joint replacement in the joint to be injected
- History of autoimmune diseases including lupus and rheumatoid arthritis
- Prior arthroscopic or open surgery of the index joint within 6 months prior to screening
See the full eligibility criteria
- Male or female, aged 18 to 95 years old
- Residents of Canada
- Written informed consent to participate in the study
- Willingness and ability to comply with the study procedures and phone visit schedules and ability to follow verbal and written instruction
- The NRS for at least 5 daily measures will be used to calculate the average score. An average NRS pain score 4-9 (moderate to severe pain).
- Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screening based on an X-ray performed within 1 year prior to screening period.
- Radiographic evidence of OA of the index knee or hip (Kellgren-Lawrence Grade I to IV) within 1 year prior to screening or during the screening period.
- Failed conservative treatment for more than 12 weeks before the screening, meaning that pain persists for more than 12 weeks after the patient tried two or more of the following medication or interventions in that...
- oral analgesics, including over-the-counter medications and supplements,
- physiotherapy
- acupuncture
- bracing
- cortisone injections,
- hyaluronic acid injections,
- dextrose injections (prolotherapy)
- platelet-rich plasma injections
- Women of childbearing potential must use an effective method of contraception from 14 days prior to baseline visit to 360 days after intervention. Effective birth control considered for this trial are total abstinence...
- Body mass index (BMI) ≤ 50 kg/m2
- Women who are pregnant or planning to become pregnant during the trial period.
- Women of childbearing potential (not surgically sterile or post-menopausal for at least one year) not using a highly effective method of contraception such as total abstinence; consistent use of birth control pills...
- History of malignancy except for the diagnosis of basal cell carcinoma, within 5 years prior to pre-screening.
- Presence of retained rods or screws or insertion or joint replacement in the joint to be injected
- History of autoimmune diseases including lupus and rheumatoid arthritis
- Prior arthroscopic or open surgery of the index joint within 6 months prior to screening
- Planned arthroscopic or open surgery of the index joint during study period
- Intra-articular injections in the index joint within 3 months prior to screening for corticosteroids or dextrose injections, and within 6 months prior to screening for hyaluronic acid or platelet-rich plasma (PRP)...
- Use of systemic immunosuppressives, immunomodulators or chemotherapeutic agents within 3 months prior to baseline visit
- Know hypersensitivity to lidocaine, epinephrine or heparin
- History of coagulopathy
- Fever (forehead temperature above 38.0 centigrade) at baseline visit
- people with cutaneous infection at the lipoaspirate or bone marrow aspirate site and/or in the area of the injection at baseline visit
- people with hemoglobin less than 10 g/L
- people with platelet count less than 155x109/L
- people participating in a study of an experimental drug or medical device within 30 days of study entry
- Any medical condition the qualified investigator believes makes the patient unsuitable for the study
- people using warfarin before the screening, with an INR above 3
The study team makes the final eligibility decision.
Where it's taking place
- Brampton, Ontario, Canada
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 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brampton, Ontario, Canada. 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.