NCT03269409 is a Phase 1 clinical trial of Lactated Ringers in Osteonecrosis, sponsored by Mayo Clinic.

Who is sponsoring NCT03269409?

NCT03269409 is sponsored by Mayo Clinic.

What drugs are being tested in NCT03269409?

Interventions in NCT03269409: Lactated Ringers, The Celution 800/GP System (Cytori Therapeutics), Adipose Derived Regenerative Cells (ADRC).

What condition does NCT03269409 study?

NCT03269409 studies Osteonecrosis.

Is NCT03269409 still recruiting?

NCT03269409 is currently terminated. Last updated 11 January 2022.

Last reviewed 2022-01-11 · How we verify

NCT03269409

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis

Terminated Phase 1 Last updated 11 January 2022

What this trial tests

Phase 1 trial testing Lactated Ringers in Osteonecrosis in 8 participants. Terminated before completion.

Timeline

15 November 2017

Primary endpoint
28 June 2021

28 June 2021

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	8
Start date	15 November 2017
Primary completion	28 June 2021
Estimated completion	28 June 2021
Sites	1 location across United States

Drugs / interventions tested

Lactated Ringers
The Celution 800/GP System (Cytori Therapeutics)
Adipose Derived Regenerative Cells (ADRC) — full drug profile →

Conditions studied

Osteonecrosis — all drugs for Osteonecrosis →

Sponsor

Mayo Clinic

Who can join

Adults 22 to 70, any sex, with Osteonecrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized clinical trial aims to determine if cells from a patient's own adipose tissue is safe and capable of helping regenerate the femoral head in patients with osteonecrosis. The standard of care is known as hip decompression which simply removes dead tissue from the femoral head and creates a new cavity to be filled in by healthy bone. This trial will use hip decompression in one hip and hip decompression supplemented with adipose derived regenerative cells in patients with osteonecrosis in both of their hips.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Adipose tissue in bone regeneration - stem cell source and beyond.
Labusca L. · · 2022 · cited 9× · PMID 35949397 · DOI 10.4252/wjsc.v14.i6.372
Bioengineering strategies targeting angiogenesis: Innovative solutions for osteonecrosis of the femoral head.
Zhu W, Xu Z, Zhou D, Xu J, et al · · 2025 · cited 4× · PMID 39866964 · DOI 10.1177/20417314241310541
Reply to the Letter to the Editor: Stem Cells Combined With Platelet-rich Plasma Effectively Treat Corticosteroid-induced Osteonecrosis of the Hip: A Prospective Study.
Houdek MT, Wyles CC, Collins MS, Howe BM, et al · · 2018 · cited 1× · PMID 29601399 · DOI 10.1007/s11999.0000000000000284

Verify or expand the search:

Other trials of Lactated Ringers

Trials testing the same drug.

NCT03066440 — Double Blinded Randomized Control Trial of Types of IVF in Children With DKA · Phase 4 · terminated

Other recruiting trials for Osteonecrosis

Currently open trials in the same condition.

NCT06016634 — Alendronate for Osteonecrosis in Adults With Sickle Cell Disease · Phase 2 · recruiting
NCT07471880 — A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head · Phase 2 · active not recruiting
NCT05734651 — PROMIS Evaluation Study · recruiting
NCT05283148 — Sickle Cell Disease (SCD) Bone Pain Study · NA · active not recruiting
NCT05603728 — Exactech Shoulder Post Market Clinical Follow-up Study · recruiting

Other Mayo Clinic trials

Trials by the same sponsor.

NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men · NA · not yet recruiting
NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration · not yet recruiting
NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, · NA · not yet recruiting
NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE) · NA · recruiting
NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03269409 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 11 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03269409.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing