NCT05147675

Brief Summary

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously and intraarticularly for the treatment of Osteoarthritis.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started Dec 2022

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2022Dec 2027

First Submitted

Initial submission to the registry

November 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

November 29, 2021

Last Update Submit

June 5, 2025

Conditions

OsteoarthritisSpinal Arthritis

Keywords

Osteoarthritisstem cell treatmentSpinal Arthritis

Outcome Measures

Primary Outcomes (1)

  • Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Four year follow-up

Secondary Outcomes (1)

  • Efficacy: Single Assessment Numeric Evaluation Score (SANE)

    Four year follow-up

Study Arms (1)

Treatment Group (AlloRx)

EXPERIMENTAL

Intravenous infusion and intraarticular injection (total dose of 100 million cells)

Biological: AlloRx

Interventions

AlloRxBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group (AlloRx)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Osteoarthritis
  • Understanding and willingness to sign a written informed consent document

You may not qualify if:

  • Active infection
  • Active cancer
  • Chronic multisystem organ failure
  • Pregnancy
  • Clinically significant Abnormalities on pre-treatment laboratory evaluation
  • Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
  • Continued drug abuse
  • Pre-menopausal women not using contraception
  • Previous organ transplant
  • Hypersensitivity to sulfur

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Athens Beverly Hills Medical Group

Glyfada, Athens, 16675, Greece

RECRUITING

Related Publications (4)

  • Wang Y, Jin W, Liu H, Cui Y, Mao Q, Fei Z, Xiang C. [CURATIVE EFFECT OF HUMAN UMBILICAL CORD MESENCHYMAL STEM CELLS BY INTRA-ARTICULAR INJECTION FOR DEGENERATIVE KNEE OSTEOARTHRITIS]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2016 Dec 8;30(12):1472-1477. doi: 10.7507/1002-1892.20160305. Chinese.

    PMID: 29786336BACKGROUND

  • Khalifeh Soltani S, Forogh B, Ahmadbeigi N, Hadizadeh Kharazi H, Fallahzadeh K, Kashani L, Karami M, Kheyrollah Y, Vasei M. Safety and efficacy of allogenic placental mesenchymal stem cells for treating knee osteoarthritis: a pilot study. Cytotherapy. 2019 Jan;21(1):54-63. doi: 10.1016/j.jcyt.2018.11.003. Epub 2018 Dec 3.

    PMID: 30522806BACKGROUND

  • Zhao X, Ruan J, Tang H, Li J, Shi Y, Li M, Li S, Xu C, Lu Q, Dai C. Multi-compositional MRI evaluation of repair cartilage in knee osteoarthritis with treatment of allogeneic human adipose-derived mesenchymal progenitor cells. Stem Cell Res Ther. 2019 Oct 21;10(1):308. doi: 10.1186/s13287-019-1406-7.

    PMID: 31639063BACKGROUND

  • Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.

    PMID: 27217345BACKGROUND

MeSH Terms

Conditions

OsteoarthritisSpondylarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSpondylitisSpinal DiseasesBone Diseases

Study Officials

  • Chadwick Prodromos, MD

    The Foundation for Orthopaedics and Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 7, 2021

Study Start

December 1, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

AN(1)GR(1)