Last reviewed · How we verify
NCT04136743: MFAT-SCI
Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury
Phase 2 trial testing Lipogems in Spinal Cord Injuries in 24 participants. Status unknown.
30 April 2023
Quick facts
| Lead sponsor | Kessler Foundation |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 14 June 2019 |
| Primary completion | 30 April 2023 |
| Estimated completion | 30 April 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lipogems
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
- Tendinopathy — all drugs for Tendinopathy →
- Rotator Cuff Tears — all drugs for Rotator Cuff Tears →
- Shoulder Pain — all drugs for Shoulder Pain →
Sponsor
Kessler Foundation
Who can join
Adults 18 to 70, any sex, with Spinal Cord Injuries or Tendinopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Corticosteroid injections are another alternative to provide temporary relief, but can over time accelerate degeneration of the tendon and lead to further damage. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI compared with the standard-of-care, corticosteroid injection.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Wharton's jelly mesenchymal stem cells: Future regenerative medicine for clinical applications in mitigation of radiation injury.
Sharma P, Maurya DK. · · 2024 · cited 12× · PMID 39086560 · DOI 10.4252/wjsc.v16.i7.742 -
Pericytes and Diabetic Microangiopathies: Tissue Resident Mesenchymal Stem Cells with High Plasticity and Regenerative Capacity.
Shirbaghaee Z, Sorenson CM, Sheibani N. · · 2025 · cited 1× · PMID 40508141 · DOI 10.3390/ijms26115333
Verify or expand the search:
- PubMed search for NCT04136743
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lipogems
Trials testing the same drug.
- NCT05594862 — Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autolo · NA · active not recruiting
- NCT04274543 — Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military · Phase 2 · completed
- NCT03913910 — Perianal Fistula Treatment With Autologous Adipose Tissue Injection · unknown
- NCT03714659 — Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears · Phase 2 · completed
- NCT03555773 — Micro-fragmented Adipose Tissue and Complex Crohns' Anal Fistulas · NA · completed
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
- NCT07109804 — Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury · NA · recruiting
- NCT07472985 — Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial · NA · recruiting
- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other Kessler Foundation trials
Trials by the same sponsor.
- NCT07168941 — Evaluation and Refinement of KF-STRIDE Into the Interview! · NA · not yet recruiting
- NCT07159100 — tDCS for Cancer-Related Fatigue and Weakness · EARLY_PHASE1 · not yet recruiting
- NCT06886152 — Spinal Stimulation and Gait Training to Improve Mobility in TBI · NA · not yet recruiting
- NCT07073313 — Using Muscle Functional MRI to Study Spatial Muscle Activation Patterns in People With SCI · not yet recruiting
- NCT06923293 — Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis · NA · 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 NCT04136743 (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 Kessler Foundation
- Last refreshed: 14 October 2022
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/NCT04136743.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing