Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

NCT03503305 | Active Not Recruiting FDA Device

• 1 other identifier: OAW-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis of the Wrist

Keywords

Adipose-derived stem cells; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Safety - Incidence of Treatment-Emergent Adverse Events

  Subjects will be monitored for adverse events

  12 months

Secondary Outcomes (3)

• Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits

  3, 6 and 12 months

• Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits

  3, 6 and 12 months

• Efficacy - Change in Function Scores on the QuickDASH at All Follow-up

  3, 6 and 12 months

Study Arms (2)

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 .

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.

Drug: Corticosteroid injection

Interventions

adipose-derived stem cell injection DEVICE

5 ml injection of adipose derived stem cells

Adipose Derived Regenerative Cell group

Corticosteroid injection DRUG

5 ml injection of corticosteroid

Corticosteroid group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• InGeneron, Inc.: lead
• Sanford Health: collaborator

Study Sites (2)

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

HD Research

Houston, Texas, 77041, United States

Location

Related Publications (3)

• 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.

  PMID: 17495232 BACKGROUND

• ter 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.

  PMID: 22961401 BACKGROUND

• Jo 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.

  PMID: 24449146 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: It is a double-blinded trial in which the subjects, investigator and radiologists are blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 19, 2018
• Study Start: November 21, 2018
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)