Last reviewed · How we verify
NCT06361485
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Phase 1 trial testing Lumbar Injections with 10cc's of Wharton's Jelly Allograft in Low Back Pain in 100 participants. Currently enrolling.
31 March 2027
Quick facts
| Lead sponsor | R3 Stem Cell |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 25 March 2024 |
| Primary completion | 31 March 2027 |
| Estimated completion | 1 April 2028 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Lumbar Injections with 10cc's of Wharton's Jelly Allograft — full drug profile →
Conditions studied
- Low Back Pain — all drugs for Low Back Pain →
Sponsor
R3 Stem Cell — full company profile →
Who can join
20 and older, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709 -
Cell-based therapies for intervertebral disc degeneration: Navigating the path from promise to clinical reality
Shi L, Jiang L, Xing T, Liu K, et al · · 2026
Verify or expand the search:
- PubMed search for NCT06361485
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Low Back Pain
Currently open trials in the same condition.
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- NCT07535047 — Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain · NA · recruiting
- NCT07463729 — Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome · NA · recruiting
- NCT07250568 — Office Program Effects on Pain, Posture, Muscle Physiology, Stress, Ergonomics, and Quality of Life in LBP Workers · NA · recruiting
- NCT07467070 — Effectiveness of Pilates on Postural Correction, Core Strength and Flexibility in Younger Individuals With Non-specific · NA · recruiting
Other R3 Stem Cell trials
Trials by the same sponsor.
- NCT03390920 — Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions · NA · not yet recruiting
- NCT03899298 — Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions · Phase 1 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT06361485 (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 R3 Stem Cell
- Last refreshed: 11 April 2024
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/NCT06361485.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing