Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InGeneron, Inc.
• Collaborator: Sanford Health

Criteria

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.