Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

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.

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.