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RecruitingNCT05147675Updated Jun 10, 2025

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for OA

A Phase 1 interventional study of AlloRx in Osteoarthritis and Spinal Arthritis, sponsored by The Foundation for Orthopaedics and Regenerative Medicine. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by The Foundation for Orthopaedics and Regenerative Medicine · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
92
Allocation
Not applicable
Sex
All
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Study 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.

Read the detailed description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Osteoarthritis (OA). This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of OA. Patients with OA will receive intravenous infusion and intraarticular injection of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

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Conditions studied

  • Osteoarthritis
  • Spinal Arthritis

Keywords

  • Osteoarthritis
  • stem cell treatment
  • Spinal Arthritis
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In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's planned enrollment of 92 is close to the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine is the lead sponsor of 33 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Treatment Group (AlloRx)

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

    Biological: AlloRx

Interventions

  • BiologicalAlloRx

    cultured allogeneic adult umbilical cord derived mesenchymal stem cells

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What researchers measure

Primary outcomes

  1. Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Time frame: Four year follow-up

Secondary outcomes

  1. Efficacy: Single Assessment Numeric Evaluation Score (SANE)

    ranging from 0 to 100%

    Time frame: Four year follow-up

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Study locations

2 of 2 sites recruiting
  • Medical Surgical Associates Center
    St. John's, Antigua and Barbuda
    Recruiting
  • Athens Beverly Hills Medical Group
    Glyfáda, Athens 16675, Greece
    Recruiting
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References and documents

Publications

  • 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. PubMed 29786336 ↗
  • 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. PubMed 30522806 ↗
  • 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. PubMed 31639063 ↗
  • 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. PubMed 27217345 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05147675
Lead sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Responsible party
Sponsor
First posted
Dec 7, 2021
Start date
Dec 1, 2022
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jun 10, 2025

Study contacts

Chadwick Prodromos, MD
principal investigator · The Foundation for Orthopaedics and Regenerative Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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