InGeneron, Inc.
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.
Osteoarthritis of the Wrist
adipose-derived stem cell injection
Corticosteroid injection
NA
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 40 participants |
Masking : | DOUBLE |
Masking Description : | It is a double-blinded trial in which the subjects, investigator and radiologists are blinded to treatment assignment. |
Primary Purpose : | TREATMENT |
Official Title : | Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells |
Actual Study Start Date : | 2018-11-21 |
Estimated Primary Completion Date : | 2024-12-31 |
Estimated Study Completion Date : | 2025-03-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
ACTIVE NOT RECRUITING
Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57105
RECRUITING
HD Research
Houston, Texas, United States, 77041