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| Name | Class |
|---|---|
| Sanford Health | OTHER |
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This is a prospective, randomized, double-blinded, active controlled, single site safety and efficacy study in subjects suffering from chronic wrist osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the wrist.
The focus of this study is to investigate the therapeutic benefit of autologous adipose-derived regenerative cells in patients with wrist arthritis. The hypothesis of this trial is that the use of adult-adipose derived regenerative cells as a treatment of wrist arthritis will induce healing and decrease pain compared to the control group. With adult-adipose derived regenerative cell administration, the medical practitioner would anticipate a reduction in inflammation, acceleration in healing, decreased pain in patients post procedure, and increased function and strength in the affected wrist. Currently, no clinical studies have been constructed to determine the efficacy of ADRCs in wrist arthritis patients.
Subjects will fall into two categories: treatment group (20) and control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive wrist osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the wrist. The control group will receive a 5 ml cortisone injection into the wrist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose Derived Regenerative Cell group | Experimental | Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection . |
|
| Corticosteroid group | Active Comparator | Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adipose-derived stem cell injection | Device | 5 ml injection of adipose derived stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Incidence of Treatment-Emergent Adverse Events | Subjects will be monitored for adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits | Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain) | 3, 6 and 12 months |
| Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57105 | United States | ||
| HD Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17495232 | Background | Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09. | |
| 22961401 | Background | ter Huurne M, Schelbergen R, Blattes R, Blom A, de Munter W, Grevers LC, Jeanson J, Noel D, Casteilla L, Jorgensen C, van den Berg W, van Lent PL. Antiinflammatory and chondroprotective effects of intraarticular injection of adipose-derived stem cells in experimental osteoarthritis. Arthritis Rheum. 2012 Nov;64(11):3604-13. doi: 10.1002/art.34626. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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It is a double-blinded trial in which the subjects, investigator and radiologists are blinded to treatment assignment.
| Corticosteroid injection | Drug | 5 ml injection of corticosteroid |
|
Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty) |
| 3, 6 and 12 months |
| Efficacy - Change in Function Scores on the QuickDASH at All Follow-up | Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable) | 3, 6 and 12 months |
| Houston |
| Texas |
| 77041 |
| United States |
| 24449146 | Background | Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634. |