Frontlight ResearchEarly access
Active, not recruitingNo phase
Healing Osteoarthritic Joints in the Wrist With Adult ADRCs
Key facts
- Who runs it
- InGeneron, Inc.
- Where
- Houston and Sioux Falls, United StatesSee the 2 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 40 people, planned
- Started
- 21 Nov 2018
- Ended
- Aug 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- adipose-derived stem cell injection
- Corticosteroid injection
- Record updated
- 20 August 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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 authorized representative available
Who cannot take part
- 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.)
- Subjects who have received a corticosteroid injection in the treatment site
- Subjects on an active regimen of chemotherapy
- Subjects who have a documented diagnosis of carpal tunnel syndrome
- History of systemic malignant or local neoplasms on affected limb within last 5 years
- Subjects who have document allergy to radiographic guidance agents
- 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
- Allergy to sodium citrate of any "caine" type of local anesthetic
- 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
- Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist
- Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate
- Subjects pregnant or breast feeding
- 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
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
Where in United States
- HD ResearchHouston, United States
- Sanford USD Medical CenterSioux Falls, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Adipose Derived Regenerative Cell groupTreatment being tested
Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection .
Treatment: adipose-derived stem cell injection
- Corticosteroid groupExisting treatment, for comparison
Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection.
Treatment: Corticosteroid injection
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells
- Record updated
- 20 August 2025