Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R Inj.) Treatment in Patients With ALS
-
- STATUS
- Recruiting
-
- End date
- May 3, 2026
-
- participants needed
- 115
-
- sponsor
- Corestem, Inc.
Summary
ALSUMMIT is a double-blind, randomized, placebo-controlled, multi-center, parallel, phase III clinical trial to evaluate and confirm the efficacy and long-term safety of repeated Lenzumestrocel (Neuronata-R inj.) treatment.
Description
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder characterized by selective and progressive loss of motor neurons. Disease progression leads to death within 2-4 years, but there exists no definite treatment so far.
Based on phase I/II clinical trial(NCT01363401), twice intrathecal autologous bone marrow-derived mesenchymal stem cells (Lenzumestrocel) injections showed significant therapeutic benefit lasting at least six months with safety in patients with ALS.
Additionally, the switch from pro- to anti-inflammatory conditions, which was indicated from the inverse correlation between TGF-1 and MCP-1 levels after Lenzumestrocel injections in the good responder, has been considered a plausible beneficial action mechanism.
This study is designed to investigate the following. First, to reconfirm and evaluate the long-term efficacy of twice injections (single cycle) of Lenzumestrocel, group 1 will receive a single cycle injection with a 26-day interval.
Second, to evaluate the long-term safety and efficacy of Lenzumestrocel repeated injections, group 2 will receive a single cycle injection a 26-day apart followed by three times injections every three-month interval.
Group 3 will receive comparator injections.
Details
| Condition | Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, Myelopathy, lou gehrig's disease, Amyotrophic Lateral Sclerosis |
|---|---|
| Treatment | Placebo Comparator, Riluzole, Lenzumestrocel |
| Clinical Study Identifier | NCT04745299 |
| Sponsor | Corestem, Inc. |
| Last Modified on | 22 October 2021 |
Eligibility
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer