Last updated: April 4, 2024
Sponsor: InGeneron, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Osteoarthritis
Treatment
adipose-derived stem cell injection
Corticosteroid injection
Clinical Study ID
NCT03503305
OAW-001
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females ages: 18 - 75.
- Clinical symptoms consistent with wrist osteoarthritis.
- Diagnosed with wrist osteoarthritis on radiographs.
- The ability of subjects to give appropriate consent or have a legally authorizedrepresentative available.
Exclusion
Exclusion Criteria:
- Subjects who have a documented history or presence of inflammatory arthritis,rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist
- Subjects who have a documented diagnosis of carpal tunnel syndrome.
- Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate
- History of systemic malignant or local neoplasms on affected limb within last 5 years
- Subject is receiving immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g., humanimmunodeficiency virus, systemic lupus erythematosus, etc.)
- Subjects who have received a corticosteroid injection in the treatment site
- Subjects on an active regimen of chemotherapy
- Allergy to sodium citrate of any "caine" type of local anesthetic
- Subjects pregnant or breast feeding
- Subject is in the opinion of the Investigator or designee, unable to comply with therequirements of the study protocol or is unsuitable for the study for any reason. Thisincludes completion of patient reported outcome instruments
- Subjects who have document allergy to radiographic guidance agents.
- Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint
- History of tobacco use within the last 3 months
- Subjects with documented with a history of alcohol or drug abuse
- Subjects who have a documented history of HIV, Hepatitis B, and Hepatitis C
- 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, adversepersonal circumstances or lack of autonomy. This may include: Individuals with mentaldisability, persons in nursing homes, children, impoverished persons, persons inemergency situations, homeless persons, nomads, refugees, and those incapable ofgiving informed consent. Vulnerable populations also may include members of a groupwith a hierarchical structure such as university students, subordinate hospital andlaboratory personnel, employees of the Sponsor, members of the armed forces, andpersons kept in detention.
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: adipose-derived stem cell injection
Phase:
Study Start date:
November 21, 2018
Estimated Completion Date:
March 31, 2025
Study Description
Connect with a study center
Sanford USD Medical Center
Sioux Falls, South Dakota 57105
United StatesSite Not Available
HD Research
Houston, Texas 77041
United StatesActive - Recruiting
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