NCT03899298

Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions

Not yet recruiting Phase 1 Last updated 22 August 2019

What this trial tests

Phase 1 trial testing Amniotic and Umbilical Cord Tissue Procedure in Orthopedic Disorder in 5,000 participants. Not yet recruiting.

Timeline

1 September 2019

Primary endpoint
20 March 2024

20 March 2029

Quick facts

Lead sponsor	R3 Stem Cell
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5,000
Start date	1 September 2019
Primary completion	20 March 2024
Estimated completion	20 March 2029

Drugs / interventions tested

• Amniotic and Umbilical Cord Tissue Procedure — full drug profile →

Conditions studied

• Orthopedic Disorder — all drugs for Orthopedic Disorder →
• Neurologic Disorder — all drugs for Neurologic Disorder →
• Urologic Diseases — all drugs for Urologic Diseases →
• Erectile Dysfunction — all drugs for Erectile Dysfunction →

Sponsor

R3 Stem Cell — full company profile →

Who can join

18 and older, any sex, with Orthopedic Disorder or Neurologic Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.

Publications & conference data

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

1. Alzheimer's disease drug development pipeline: 2023.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
2. New idea to promote the clinical applications of stem cells or their extracellular vesicles in central nervous system disorders: Combining with intranasal delivery.
   Li Y, Wu H, Jiang X, Dong Y, et al · · 2022 · cited 28× · PMID 35967290 · DOI 10.1016/j.apsb.2022.04.001
3. Stem Cell-based Therapeutic and Diagnostic Approaches in Alzheimer's Disease.
   Abdi S, Javanmehr N, Ghasemi-Kasman M, Bali HY, et al · · 2022 · cited 26× · PMID 34970956 · DOI 10.2174/1570159x20666211231090659
4. Locoregional delivery of stem cell-based therapies.
   Ng NN, Thakor AS. · · 2020 · cited 24× · PMID 32522806 · DOI 10.1126/scitranslmed.aba4564
5. Advances in stem cell therapy in Alzheimer's disease: a comprehensive clinical trial review.
   Karvelas N, Bennett S, Politis G, Kouris NI, et al · · 2022 · cited 20× · PMID 35280344 · DOI 10.21037/sci-2021-063
6. Mechanism of inflammatory response and therapeutic effects of stem cells in ischemic stroke: current evidence and future perspectives.
   Wang Y, Yuan T, Lyu T, Zhang L, et al · · 2025 · cited 16× · PMID 38767477 · DOI 10.4103/1673-5374.393104
7. Mesenchymal Stromal Cell-Based Products: Challenges and Clinical Therapeutic Options.
   Mello DB, Mesquita FCP, Silva Dos Santos D, Asensi KD, et al · · 2024 · cited 15× · PMID 38892249 · DOI 10.3390/ijms25116063
8. Allogenic Perinatal Tissue for Musculoskeletal Regenerative Medicine Applications: A Systematic Review.
   Aratikatla A, Maffulli N, Rodriguez HC, Gupta M, et al · · 2022 · cited 14× · PMID 36551929 · DOI 10.3390/biomedicines10123173