Osteoarthritis of the Wrist
Conditions
Keywords
Adipose-derived stem cells, osteoarthritis
Brief summary
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.
Detailed description
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.
Interventions
5 ml injection of adipose derived stem cells
DRUGCorticosteroid injection
5 ml injection of corticosteroid
Sponsors
Sanford Health
InGeneron, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
It is a double-blinded trial in which the subjects, investigator and radiologists are blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females ages: 18 - 75. 2. Clinical symptoms consistent with wrist osteoarthritis. 3. Diagnosed with wrist osteoarthritis on radiographs. 4. The ability of subjects to give appropriate consent or have a legally authorized representative available.
Exclusion criteria
1. Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist 2. Subjects who have a documented diagnosis of carpal tunnel syndrome. 3. Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate 4. History of systemic malignant or local neoplasms on affected limb within last 5 years 5. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.) 6. Subjects who have received a corticosteroid injection in the treatment site 7. Subjects on an active regimen of chemotherapy 8. Allergy to sodium citrate of any caine type of local anesthetic 9. Subjects pregnant or breast feeding 10. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments 11. Subjects who have document allergy to radiographic guidance agents. 12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint 13. History of tobacco use within the last 3 months 14. Subjects with documented with a history of alcohol or drug abuse 15. Subjects who have a documented history of HIV, Hepatitis B, and Hepatitis C 16. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Incidence of Treatment-Emergent Adverse Events | 12 months | Subjects will be monitored for adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits | 3, 6 and 12 months | Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain) |
| Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits | 3, 6 and 12 months | Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty) |
| Efficacy - Change in Function Scores on the QuickDASH at All Follow-up | 3, 6 and 12 months | Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable) |
Countries
United States
Outcome results
None listed