Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
All Cohorts: To be eligible to participate in this study, a subject must meet all the following criteria. Inclusion Criteria-ALL Cohorts: 1. Men and women age 18 or older. 2. Clinical and radiographic diagnosis of OA in one of the following areas: Ankle, Hip, Knee, Shoulder, or Wrist. 3. Continued OA pain in the targeted joint despite conservative measures (per treating provider's discretion) 4. Average daily VAS Pain Score ≥3. 5. Understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures. 6. Subject must also meet additional inclusion criteria specific to the targeted joint cohort. Ankle Cohort: 1. Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray (weight-bearing mortise views with 20⁰ internal rotation) 2. Ankle pain for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications. 3. Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane. Hip Cohort: 1. Hip OA diagnosed on x-ray and/or Magnetic Resonance Imaging (MRI) (Tӧnnis grade 1, 2, or 3) Knee Cohort: 1. Kellgren-Lawrence system of Grade II, III, or
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|David A. Pearce, PhD|
|Principal Investigator Affiliation||Sanford Health|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Knee Osteoarthritis, Hip Osteoarthritis, Ankle Osteoarthritis, Shoulder Osteoarthritis, Wrist Osteoarthritis|
Subjects who have signed informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization, and are determined to meet all inclusion criteria and no exclusion criteria will be enrolled in this study and receive the ADRC treatment. The subject will have an injection procedure (ADRC treatment) For this study, a licensed physician trained in liposuction must perform the syringe liposuction procedure. The licensed physician who performs the lipoplasty may be the Investigator or a non-Investigator physician (e.g., a plastic surgeon) who is trained on the study protocol. All subjects will undergo a minor syringe liposuction procedure to acquire approximately 100 mL of lipoaspirate for preparation of ADRC using the Transpose® RT System. The removed tissue is processed to extract a cell suspension (the cell product). Once the cell product has been obtained, tested, and found to conform to release criteria, the subject will be treated with the ADRCs.
: Hip Osteoarthritis
Subjects will receive autologous adipose-derived regenerative stem cells into their affected hip joint.
: Knee Osteoarthritis
Subjects will receive autologous adipose-derived regenerative stem cells into their affected knee joint.
: Ankle Osteoarthritis
Subjects will receive autologous adipose-derived regenerative stem cells into their affected ankle joint.
: Shoulder Osteoarthritis
Subjects will receive autologous adipose-derived regenerative stem cells into their affected shoulder joint.
: Wrist Osteoarthritis
Subjects will receive autologous adipose-derived regenerative stem cells into their affected wrist joint.
Device: - Adipose-derived regenerative cells
Adipose-derived regenerative cells will be obtained from a small-volume lipoaspirate procedure. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the targeted joint.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.