ACTIVE_NOT_RECRUITING

Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Conditions

Osteoarthritis of the Wrist Adipose-derived stem cells osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-11-21

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03503305

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105

United States

HD Research

Houston, Texas, 77041

United States

Collaborators and Investigators

Sponsor: InGeneron, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-21

Study Completion Date2026-08

Study Record Updates

Study Start Date2018-11-21

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Adipose-derived stem cells
osteoarthritis

Additional Relevant MeSH Terms

Osteoarthritis of the Wrist