NCT01771679

Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging

Status unknown Phase 1, PHASE2 Last updated 31 October 2022

What this trial tests

Phase 1, PHASE2 trial testing Allogeneic Mesenchymal Bone Marrow Cells in Chronic Effect of Ultraviolet Radiation on Photoaged Skin in 29 participants. Status unknown.

Timeline

1 July 2015

Primary endpoint
30 April 2024

31 December 2024

Quick facts

Lead sponsor	Stemedica Cell Technologies, Inc.
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	1 July 2015
Primary completion	30 April 2024
Estimated completion	31 December 2024
Sites	2 locations across United States

Drugs / interventions tested

• Allogeneic Mesenchymal Bone Marrow Cells — full drug profile →

Conditions studied

• Chronic Effect of Ultraviolet Radiation on Photoaged Skin — all drugs for Chronic Effect of Ultraviolet Radiation on Photoaged Skin →
• Dermatologic Disorders — all drugs for Dermatologic Disorders →

Sponsor

Stemedica Cell Technologies, Inc. — full company profile →

Who can join

Adults 40 to 70, any sex, with Chronic Effect of Ultraviolet Radiation on Photoaged Skin or Dermatologic Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine whether a one-time injection of allogeneic mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the face.

Publications & conference data

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

1. Current regenerative medicine-based approaches for skin regeneration: A review of literature and a report on clinical applications in Japan.
   Shimizu Y, Ntege EH, Sunami H. · · 2022 · cited 32× · PMID 35785041 · DOI 10.1016/j.reth.2022.05.008
2. Human Mesenchymal Stem/Stromal Cells in Immune Regulation and Therapy.
   Mezey É. · · 2022 · cited 28× · PMID 35298659 · DOI 10.1093/stcltm/szab020
3. Recent clinical trials with stem cells to slow or reverse normal aging processes.
   Garay RP. · · 2023 · cited 14× · PMID 37090485 · DOI 10.3389/fragi.2023.1148926
4. An Update on the Potential of Mesenchymal Stem Cell Therapy for Cutaneous Diseases.
   Li Y, Ye Z, Yang W, Zhang Q, et al · · 2021 · cited 12× · PMID 33505474 · DOI 10.1155/2021/8834590
5. The use of stem cells in aesthetic dermatology and plastic surgery procedures. A compact review of experimental and clinical applications.
   Nowacki M, Kloskowski T, Pietkun K, Zegarski M, et al · · 2017 · cited 7× · PMID 29422816 · DOI 10.5114/ada.2017.72456
6. Preventing MSC aging and enhancing immunomodulation: Novel strategies for cell-based therapies.
   Elmi F, Soltanmohammadi F, Fayeghi T, Farajnia S, et al · · 2025 · cited 5× · PMID 40453699 · DOI 10.1016/j.reth.2025.04.014
7. Radiation-induced gastrointestinal and cutaneous injuries: understanding models, pathologies, assessments, and clinically accepted practices.
   Tamarat R, Satyamitra MM, Benderitter M, DiCarlo AL. · · 2024 · cited 5× · PMID 38787685 · DOI 10.1080/09553002.2024.2356544