NCT03279796

Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells

Status unknown Phase 2 Last updated 26 April 2018

What this trial tests

Phase 2 trial testing Autologous adipose-derived MSCs in Rotator Cuff Tear in 200 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
31 December 2019

31 December 2021

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	1 October 2018
Primary completion	31 December 2019
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

• Autologous adipose-derived MSCs — full drug profile →
• Compound betamethasone

Conditions studied

• Rotator Cuff Tear — all drugs for Rotator Cuff Tear →
• Lateral Epicondylitis — all drugs for Lateral Epicondylitis →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 90, any sex, with Rotator Cuff Tear or Lateral Epicondylitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1\*10\^6 cells as an unit. Patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1\*10\^6/10kg) while the control group received the same dose compound betamethasone injection. Follow up visit for all patients will occur at 1，3，6 and 12 months after the first injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

Publications & conference data

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

1. Mesenchymal Stem Cells Empowering Tendon Regenerative Therapies.
   Costa-Almeida R, Calejo I, Gomes ME. · · 2019 · cited 102× · PMID 31248196 · DOI 10.3390/ijms20123002
2. Mechanism of Action of Mesenchymal Stem Cells (MSCs): impact of delivery method.
   Bagno LL, Salerno AG, Balkan W, Hare JM. · · 2022 · cited 49× · PMID 34882517 · DOI 10.1080/14712598.2022.2016695
3. Cell-based therapy in the treatment of musculoskeletal diseases.
   Trapana J, Weinerman J, Lee D, Sedani A, et al · · 2024 · cited 18× · PMID 39226104 · DOI 10.1093/stcltm/szae049
4. Cell-Based Therapies for Rotator Cuff Injuries: An Updated Review of the Literature.
   Hooper N, Marathe A, Jain NB, Jain NB, et al · · 2024 · cited 10× · PMID 38542113 · DOI 10.3390/ijms25063139
5. Epigenetic mechanisms in stem cell therapies for achilles tendinopathy.
   Yuan Z, Yao Z, Mao X, Gao X, et al · · 2025 · PMID 40181824 · DOI 10.3389/fcell.2025.1516250