Trials / Terminated
TerminatedNCT04405297
A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 14 (actual)
- Sponsor
- Sanford Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle.
Detailed description
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.
Conditions
- Knee Osteoarthritis
- Hip Osteoarthritis
- Ankle Osteoarthritis
- Shoulder Osteoarthritis
- Wrist Osteoarthritis
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2024-09-23
- Completion
- 2024-09-23
- First posted
- 2020-05-28
- Last updated
- 2025-10-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04405297. Inclusion in this directory is not an endorsement.