Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Description

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.

Conditions

Osteoarthritis of the Wrist

Study Overview

Study Details

Study overview

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.

Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells

Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Condition
Osteoarthritis of the Wrist
Intervention / Treatment

-

Contacts and Locations

Sioux Falls

Sanford USD Medical Center, Sioux Falls, South Dakota, United States, 57105

Houston

HD Research, Houston, Texas, United States, 77041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

InGeneron, Inc.,

Robert Vandermark, MD, PRINCIPAL_INVESTIGATOR, Sanford Health

Study Record Dates

2025-03-31