Osteoarthritis of the WristNCT03503305
Healing Osteoarthritic Joints in the Wrist With Adult ADRCs
A study testing adipose-derived stem cell injection and Corticosteroid injection in people with Osteoarthritis of the Wrist, run by InGeneron, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Wrist
- What is being tested?
- adipose-derived stem cell injection and Corticosteroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2018to Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 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
Show all 16Show fewer
- 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 the requirements of the study protocol or is unsuitable for the study for any reason. This includes 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 yet completed 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, 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HD Research
Houston, Texas, 77041
Sanford USD Medical Center
Sioux Falls, South Dakota, 57105
About this study
Official title: Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells
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.
Read the detailed description
The focus of this study is to investigate the therapeutic benefit of autologous adipose-derived regenerative cells in patients with wrist arthritis. The hypothesis of this trial is that the use of adult-adipose derived regenerative cells as a treatment of wrist arthritis will induce healing and decrease pain compared to the control group. With adult-adipose derived regenerative cell administration, the medical practitioner would anticipate a reduction in inflammation, acceleration in healing, decreased pain in patients post procedure, and increased function and strength in the affected wrist. Currently, no clinical studies have been constructed to determine the efficacy of ADRCs in wrist arthritis patients.
Subjects will fall into two categories: treatment group (20) and control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive wrist osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the wrist. The control group will receive a 5 ml cortisone injection into the wrist.
- Conditions
- Osteoarthritis of the Wrist
- Being tested
- adipose-derived stem cell injection, Corticosteroid injection
- Keywords
- Adipose-derived stem cells, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose-derived stem cell injectionDevice
5 ml injection of adipose derived stem cells
Corticosteroid injectionDrug
5 ml injection of corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Adipose Derived Regenerative Cell group | Experimental | Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection . Receives: Device: adipose-derived stem cell injection |
| Corticosteroid group | Active comparator | Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection. Receives: Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Incidence of Treatment-Emergent Adverse Events
Subjects will be monitored for adverse events
Measured: 12 months
Secondary outcomes (3)
Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits
Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)
Measured: 3, 6 and 12 months
Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits
Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty)
Measured: 3, 6 and 12 months
Efficacy - Change in Function Scores on the QuickDASH at All Follow-up
Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable)
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start21 Nov 2018
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the WristStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InGeneron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanford Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503305
- Sponsor's protocol ID
- OAW-001
- Status last verified
- Aug 2025
- First submitted
- 5 Apr 2018
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.
PubMed 17495232ter Huurne M, Schelbergen R, Blattes R, Blom A, de Munter W, Grevers LC, Jeanson J, Noel D, Casteilla L, Jorgensen C, van den Berg W, van Lent PL. Antiinflammatory and chondroprotective effects of intraarticular injection of adipose-derived stem cells in experimental osteoarthritis. Arthritis Rheum. 2012 Nov;64(11):3604-13. doi: 10.1002/art.34626.
PubMed 22961401Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634.
PubMed 24449146