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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